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1. Availability of HLA-allele-matched unrelated donors and registry size: Estimation from haplotype frequency in the Italian population

Author: Sacchi, N., Ciceri, F., Bonifazi, F., Algeri, M., Gallina, A., Pollichieni, S., Raggio, E., Hadj-Amar, B., Lombardini, L., Pupella, S., Liumbruno, G., and Cardillo, M.
Published: 2021
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2. Gilteritinib as Post-Transplant Maintenance for Acute Myeloid Leukemia With Internal Tandem Duplication Mutation of FLT3

Author: Levis, M, Hamadani, M, Logan, B, Jones, R, Singh, A, Litzow, M, Wingard, J, Papadopoulos, E, Perl, A, Soiffer, R, Ustun, C, Ueda Oshima, M, Uy, G, Waller, E, Vasu, S, Solh, M, Mishra, A, Muffly, L, Kim, H, Mikesch, J, Najima, Y, Onozawa, M, Thomson, K, Nagler, A, Wei, A, Marcucci, G, Geller, N, Hasabou, N, Delgado, D, Rosales, M, Hill, J, Gill, S, Nuthethi, R, King, D, Wittsack, H, Mendizabal, A, Devine, S, Horowitz, M, Chen, Y, Agura, E, Altman, J, Anagnostopoulos, A, Anand, S, Artz, A, Aulitzky, W, Balderman, S, Ballen, K, Becker, M, Beguin, Y, Berkahn, L, Berneman, Z, Bhatt, V, Bilmon, I, Bonifazi, F, Briggs, A, Bruno, B, Brunstein, C, Byrne, M, Byrne, J, Cabrero, M, Cairoli, R, Carrum, G, Cerny, J, Cheong, J, Ciceri, F, Colorado, M, Cook, R, Couriel, D, Craddock, C, Damon, L, Deol, A, Desbrosses, Y, Di Grazia, C, Di Stasi, A, Dias, A, Dorritie, K, Essell, J, Eto, T, Farag, S, Forcade, E, Frankfurt, O, Fujiwara, S, Fukuda, T, Fukushima, K, Furst, S, Goto, T, Hall, A, Hatta, S, Hicheri, Y, Horwitz, M, Hou, H, How, J, Howard, D, Hsu, W, Huynh, A, Irvine, D, Ishikawa, T, Jamieson, K, Jedrzejczak, W, Jethava, Y, Jimenez, A, Jung, C, Kanda, J, Karakasis, D, Kato, J, Kekre, N, Khera, N, Klein, A, Kobbe, G, Kornblit, B, Kota, V, Lachance, S, Leber, B, Lee, C, Lee, J, Lin, T, Liu, T, Martelli, M, Martinez, C, Matsuoka, K, Mccarty, J, Mendez, L, Michelis, F, Mineishi, S, Mohty, M, Moors, I, Motyckova, G, Mueller, L, Nakamae, H, Nakano, N, Nathan, S, Nicholson, E, Norkin, M, Ogawa, Y, Olesen, G, Oluwole, O, Pantin, J, Paulson, K, Pemberton, L, Perera, T, Piatkowska-Jakubas, B, Poire, X, Protheroe, R, Rambaldi, A, Ritchie, D, Ross, K, Rubio, M, Santarone, S, Sanz Caballer, J, Sawa, M, Schaar, D, Scheid, C, Schriber, J, Seropian, S, Shah, N, Shore, T, Gil, J, Sobecks, R, Socie, G, Sprague, K, Spyridonidis, A, Stelljes, M, Stiff, P, Stuart, R, Tanaka, M, Tandra, A, Tholouli, E, Thomas, X, Tiribelli, M, Tomlinson, B, Tsirigotis, P, Tzachanis, D, Uchida, N, Ueda, M, Valcarcel Ferreiras, D, Wagner, E, Watson, A, Weisdorf, D, Wolschke, C, Wrobel, T, Yakoub-Agha, I, Yamauchi, T, Yared, J, Yeh, S, Yoon, S, Yoshihara, S, Null, N, Levis, Mark J., Hamadani, Mehdi, Logan, Brent, Jones, Richard J., Singh, Anurag K., Litzow, Mark, Wingard, John R., Papadopoulos, Esperanza B., Perl, Alexander E., Soiffer, Robert J., Ustun, Celalettin, Ueda Oshima, Masumi, Uy, Geoffrey L., Waller, Edmund K., Vasu, Sumithra, Solh, Melhem, Mishra, Asmita, Muffly, Lori, Kim, Hee-Je, Mikesch, Jan-Henrik, Najima, Yuho, Onozawa, Masahiro, Thomson, Kirsty, Nagler, Arnon, Wei, Andrew H., Marcucci, Guido, Geller, Nancy L., Hasabou, Nahla, Delgado, David, Rosales, Matt, Hill, Jason, Gill, Stanley C., Nuthethi, Rishita, King, Denise, Wittsack, Heather, Mendizabal, Adam, Devine, Steven M., Horowitz, Mary M., Chen, Yi-Bin, Agura, Ed, Altman, Jessica, Anagnostopoulos, Achiles, Anand, Sarah, Artz, Andrew, Aulitzky, Walter, Balderman, Sophia, Ballen, Karen, Becker, Michael, Beguin, Yves, Berkahn, Leanne, Berneman, Zwi, Bhatt, Vijaya, Bilmon, Ian, Bonifazi, Francesca, Briggs, Adrienne, Bruno, Benedetto, Brunstein, Claudio, Byrne, Michael, Byrne, Jenny, Cabrero, Monica, Cairoli, Roberto, Carrum, George, Cerny, Jan, Cheong, June-Won, Ciceri, Fabio, Colorado, Mercedes, Cook, Rachel, Couriel, Daniel, Craddock, Charles, Damon, Lloyd, Deol, Abhinav, Desbrosses, Yohan, Devine, Steve, Di Grazia, Carmela, Di Stasi, Antonio, Dias, Ajoy, Dorritie, Kathy, Essell, James, Eto, Tetsuya, Farag, Sherif, Forcade, Edouard, Frankfurt, Olga, Fujiwara, Shinichiro, Fukuda, Takahiro, Fukushima, Kentaro, Furst, Sabine, Goto, Tatsunori, Hall, Aric, Hatta, Shunsuke, Hicheri, Yosr, Horwitz, Mitchell, Hou, Hsin-An, How, Jonathan, Howard, Dianna, Hsu, Wei-Hsun (Blake), Huynh, Anne, Irvine, David, Ishikawa, Takayuki, Jamieson, Katarzyna, Jedrzejczak, Wieslaw, Jethava, Yogesh, Jimenez, Antonio, Jung, Chul Won, Kanda, Junya, Karakasis, Dimitrios, Kato, Jun, Kekre, Natasha, Khera, Nandita, Klein, Andreas, Kobbe, Guido, Kornblit, Brian, Kota, Vamsi, Lachance, Silvy, Leber, Brian, Lee, Catherine, Lee, Je Hwan, Lin, Tung-Liang, Liu, Ta-Chih, Martelli, Maurizio, Martinez, Carmen, Matsuoka, Kenichi, McCarty, John, Mendez, Lourdes, Michelis, Fotios, Mineishi, Shin, Mohty, Mohamad, Moors, Ine, Motyckova, Gabriela, Mueller, Lutz, Nakamae, Hirohisa, Nakano, Nobuaki, Nathan, Sunita, Nicholson, Emma, Norkin, Maxim, Ogawa, Yoshiaki, Olesen, Gitte, Oluwole, Olalekan, Pantin, Jeremy, Paulson, Kristjan, Pemberton, Lucy, Perera, Travis, Piatkowska-Jakubas, Beata, Poire, Xavier, Protheroe, Rachel, Rambaldi, Alessandro, Ritchie, David, Ross, Kelly, Rubio, Marie-Therese, Santarone, Stella, Sanz Caballer, Jaime, Sawa, Masashi, Schaar, Dale, Scheid, Christoph, Schriber, Jeffrey, Seropian, Stuart, Shah, Nilay, Shah, Nirav, Shore, Tsiporah, Gil, Jorge Sierra, Singh, Anurag, Sobecks, Ronald, Socie, Gerard, Soiffer, Robert, Sprague, Kellie, Spyridonidis, Alexandros, Stelljes, Matthias, Stiff, Patrick, Stuart, Robert, Tanaka, Masatsugu, Tandra, Anand, Tholouli, Eleni, Thomas, Xavier, Tiribelli, Mario, Tomlinson, Benjamin, Tsirigotis, Panagiotis, Tzachanis, Dimitrios, Uchida, Naoyuki, Ueda, Masumi, Valcarcel Ferreiras, David, Wagner, Eva, Watson, Anne-Marie, Weisdorf, Daniel, Wolschke, Christine, Wrobel, Tomasz, Yakoub-Agha, Ibrahim, Yamauchi, Takuji, Yared, Jean, Yeh, Su-Peng, Yoon, Sung-Soo, Yoshihara, Satoshi, null, null, Levis, M, Hamadani, M, Logan, B, Jones, R, Singh, A, Litzow, M, Wingard, J, Papadopoulos, E, Perl, A, Soiffer, R, Ustun, C, Ueda Oshima, M, Uy, G, Waller, E, Vasu, S, Solh, M, Mishra, A, Muffly, L, Kim, H, Mikesch, J, Najima, Y, Onozawa, M, Thomson, K, Nagler, A, Wei, A, Marcucci, G, Geller, N, Hasabou, N, Delgado, D, Rosales, M, Hill, J, Gill, S, Nuthethi, R, King, D, Wittsack, H, Mendizabal, A, Devine, S, Horowitz, M, Chen, Y, Agura, E, Altman, J, Anagnostopoulos, A, Anand, S, Artz, A, Aulitzky, W, Balderman, S, Ballen, K, Becker, M, Beguin, Y, Berkahn, L, Berneman, Z, Bhatt, V, Bilmon, I, Bonifazi, F, Briggs, A, Bruno, B, Brunstein, C, Byrne, M, Byrne, J, Cabrero, M, Cairoli, R, Carrum, G, Cerny, J, Cheong, J, Ciceri, F, Colorado, M, Cook, R, Couriel, D, Craddock, C, Damon, L, Deol, A, Desbrosses, Y, Di Grazia, C, Di Stasi, A, Dias, A, Dorritie, K, Essell, J, Eto, T, Farag, S, Forcade, E, Frankfurt, O, Fujiwara, S, Fukuda, T, Fukushima, K, Furst, S, Goto, T, Hall, A, Hatta, S, Hicheri, Y, Horwitz, M, Hou, H, How, J, Howard, D, Hsu, W, Huynh, A, Irvine, D, Ishikawa, T, Jamieson, K, Jedrzejczak, W, Jethava, Y, Jimenez, A, Jung, C, Kanda, J, Karakasis, D, Kato, J, Kekre, N, Khera, N, Klein, A, Kobbe, G, Kornblit, B, Kota, V, Lachance, S, Leber, B, Lee, C, Lee, J, Lin, T, Liu, T, Martelli, M, Martinez, C, Matsuoka, K, Mccarty, J, Mendez, L, Michelis, F, Mineishi, S, Mohty, M, Moors, I, Motyckova, G, Mueller, L, Nakamae, H, Nakano, N, Nathan, S, Nicholson, E, Norkin, M, Ogawa, Y, Olesen, G, Oluwole, O, Pantin, J, Paulson, K, Pemberton, L, Perera, T, Piatkowska-Jakubas, B, Poire, X, Protheroe, R, Rambaldi, A, Ritchie, D, Ross, K, Rubio, M, Santarone, S, Sanz Caballer, J, Sawa, M, Schaar, D, Scheid, C, Schriber, J, Seropian, S, Shah, N, Shore, T, Gil, J, Sobecks, R, Socie, G, Sprague, K, Spyridonidis, A, Stelljes, M, Stiff, P, Stuart, R, Tanaka, M, Tandra, A, Tholouli, E, Thomas, X, Tiribelli, M, Tomlinson, B, Tsirigotis, P, Tzachanis, D, Uchida, N, Ueda, M, Valcarcel Ferreiras, D, Wagner, E, Watson, A, Weisdorf, D, Wolschke, C, Wrobel, T, Yakoub-Agha, I, Yamauchi, T, Yared, J, Yeh, S, Yoon, S, Yoshihara, S, Null, N, Levis, Mark J., Hamadani, Mehdi, Logan, Brent, Jones, Richard J., Singh, Anurag K., Litzow, Mark, Wingard, John R., Papadopoulos, Esperanza B., Perl, Alexander E., Soiffer, Robert J., Ustun, Celalettin, Ueda Oshima, Masumi, Uy, Geoffrey L., Waller, Edmund K., Vasu, Sumithra, Solh, Melhem, Mishra, Asmita, Muffly, Lori, Kim, Hee-Je, Mikesch, Jan-Henrik, Najima, Yuho, Onozawa, Masahiro, Thomson, Kirsty, Nagler, Arnon, Wei, Andrew H., Marcucci, Guido, Geller, Nancy L., Hasabou, Nahla, Delgado, David, Rosales, Matt, Hill, Jason, Gill, Stanley C., Nuthethi, Rishita, King, Denise, Wittsack, Heather, Mendizabal, Adam, Devine, Steven M., Horowitz, Mary M., Chen, Yi-Bin, Agura, Ed, Altman, Jessica, Anagnostopoulos, Achiles, Anand, Sarah, Artz, Andrew, Aulitzky, Walter, Balderman, Sophia, Ballen, Karen, Becker, Michael, Beguin, Yves, Berkahn, Leanne, Berneman, Zwi, Bhatt, Vijaya, Bilmon, Ian, Bonifazi, Francesca, Briggs, Adrienne, Bruno, Benedetto, Brunstein, Claudio, Byrne, Michael, Byrne, Jenny, Cabrero, Monica, Cairoli, Roberto, Carrum, George, Cerny, Jan, Cheong, June-Won, Ciceri, Fabio, Colorado, Mercedes, Cook, Rachel, Couriel, Daniel, Craddock, Charles, Damon, Lloyd, Deol, Abhinav, Desbrosses, Yohan, Devine, Steve, Di Grazia, Carmela, Di Stasi, Antonio, Dias, Ajoy, Dorritie, Kathy, Essell, James, Eto, Tetsuya, Farag, Sherif, Forcade, Edouard, Frankfurt, Olga, Fujiwara, Shinichiro, Fukuda, Takahiro, Fukushima, Kentaro, Furst, Sabine, Goto, Tatsunori, Hall, Aric, Hatta, Shunsuke, Hicheri, Yosr, Horwitz, Mitchell, Hou, Hsin-An, How, Jonathan, Howard, Dianna, Hsu, Wei-Hsun (Blake), Huynh, Anne, Irvine, David, Ishikawa, Takayuki, Jamieson, Katarzyna, Jedrzejczak, Wieslaw, Jethava, Yogesh, Jimenez, Antonio, Jung, Chul Won, Kanda, Junya, Karakasis, Dimitrios, Kato, Jun, Kekre, Natasha, Khera, Nandita, Klein, Andreas, Kobbe, Guido, Kornblit, Brian, Kota, Vamsi, Lachance, Silvy, Leber, Brian, Lee, Catherine, Lee, Je Hwan, Lin, Tung-Liang, Liu, Ta-Chih, Martelli, Maurizio, Martinez, Carmen, Matsuoka, Kenichi, McCarty, John, Mendez, Lourdes, Michelis, Fotios, Mineishi, Shin, Mohty, Mohamad, Moors, Ine, Motyckova, Gabriela, Mueller, Lutz, Nakamae, Hirohisa, Nakano, Nobuaki, Nathan, Sunita, Nicholson, Emma, Norkin, Maxim, Ogawa, Yoshiaki, Olesen, Gitte, Oluwole, Olalekan, Pantin, Jeremy, Paulson, Kristjan, Pemberton, Lucy, Perera, Travis, Piatkowska-Jakubas, Beata, Poire, Xavier, Protheroe, Rachel, Rambaldi, Alessandro, Ritchie, David, Ross, Kelly, Rubio, Marie-Therese, Santarone, Stella, Sanz Caballer, Jaime, Sawa, Masashi, Schaar, Dale, Scheid, Christoph, Schriber, Jeffrey, Seropian, Stuart, Shah, Nilay, Shah, Nirav, Shore, Tsiporah, Gil, Jorge Sierra, Singh, Anurag, Sobecks, Ronald, Socie, Gerard, Soiffer, Robert, Sprague, Kellie, Spyridonidis, Alexandros, Stelljes, Matthias, Stiff, Patrick, Stuart, Robert, Tanaka, Masatsugu, Tandra, Anand, Tholouli, Eleni, Thomas, Xavier, Tiribelli, Mario, Tomlinson, Benjamin, Tsirigotis, Panagiotis, Tzachanis, Dimitrios, Uchida, Naoyuki, Ueda, Masumi, Valcarcel Ferreiras, David, Wagner, Eva, Watson, Anne-Marie, Weisdorf, Daniel, Wolschke, Christine, Wrobel, Tomasz, Yakoub-Agha, Ibrahim, Yamauchi, Takuji, Yared, Jean, Yeh, Su-Peng, Yoon, Sung-Soo, Yoshihara, Satoshi, and null, null
Abstract: PURPOSEAllogeneic hematopoietic cell transplantation (HCT) improves outcomes for patients with AML harboring an internal tandem duplication mutation of FLT3 (FLT3-ITD) AML. These patients are routinely treated with a FLT3 inhibitor after HCT, but there is limited evidence to support this. Accordingly, we conducted a randomized trial of post-HCT maintenance with the FLT3 inhibitor gilteritinib (ClinicalTrials.gov identifier: NCT02997202) to determine if all such patients benefit or if detection of measurable residual disease (MRD) could identify those who might benefit.METHODSAdults with FLT3-ITD AML in first remission underwent HCT and were randomly assigned to placebo or 120 mg once daily gilteritinib for 24 months after HCT. The primary end point was relapse-free survival (RFS). Secondary end points included overall survival (OS) and the effect of MRD pre- and post-HCT on RFS and OS.RESULTSThree hundred fifty-six participants were randomly assigned post-HCT to receive gilteritinib or placebo. Although RFS was higher in the gilteritinib arm, the difference was not statistically significant (hazard ratio [HR], 0.679 [95% CI, 0.459 to 1.005]; two-sided P =.0518). However, 50.5% of participants had MRD detectable pre- or post-HCT, and, in a prespecified subgroup analysis, gilteritinib was beneficial in this population (HR, 0.515 [95% CI, 0.316 to 0.838]; P =.0065). Those without detectable MRD showed no benefit (HR, 1.213 [95% CI, 0.616 to 2.387]; P =.575).CONCLUSIONAlthough the overall improvement in RFS was not statistically significant, RFS was higher for participants with detectable FLT3-ITD MRD pre- or post-HCT who received gilteritinib treatment. To our knowledge, these data are among the first to support the effectiveness of MRD-based post-HCT therapy.
Published: 2024

3. Axicabtagene ciloleucel treatment is more effective in primary mediastinal large B-cell lymphomas than in diffuse large B-cell lymphomas: the Italian CART-SIE study

Author: Chiappella, A., Casadei, B., Chiusolo, Patrizia, Di Rocco, A., Ljevar, S., Magni, M., Angelillo, P., Barbui, A. M., Cutini, I., Dodero, A., Bonifazi, F., Tisi, M. C., Bramanti, S., Musso, M., Farina, M., Martino, M., Novo, M., Grillo, G., Patriarca, F., Zacchi, G., Krampera, M., Pennisi, M., Galli, Eugenio, Martelli, M., Ferreri, A. J. M., Ferrari, S., Saccardi, R., Bermema, A., Guidetti, A., Miceli, R., Zinzani, P. L., Corradini, P., Chiusolo P. (ORCID:0000-0002-1355-1587), Galli E., Chiappella, A., Casadei, B., Chiusolo, Patrizia, Di Rocco, A., Ljevar, S., Magni, M., Angelillo, P., Barbui, A. M., Cutini, I., Dodero, A., Bonifazi, F., Tisi, M. C., Bramanti, S., Musso, M., Farina, M., Martino, M., Novo, M., Grillo, G., Patriarca, F., Zacchi, G., Krampera, M., Pennisi, M., Galli, Eugenio, Martelli, M., Ferreri, A. J. M., Ferrari, S., Saccardi, R., Bermema, A., Guidetti, A., Miceli, R., Zinzani, P. L., Corradini, P., Chiusolo P. (ORCID:0000-0002-1355-1587), and Galli E.
Abstract: Axicabtagene ciloleucel showed efficacy for relapsed/refractory large B-cell lymphomas (LBCL), including primary mediastinal B-cell lymphomas (PMBCL); however, only few PMBCLs were reported. Aim was to evaluate efficacy and safety of axicabtagene ciloleucel in patients with PMBCL compared to those with other LBCL, enrolled in the Italian prospective observational CART-SIE study. PMBCLs (n = 70) were younger, with higher percentage of bulky and refractory disease, compared to other LBCLs (n = 190). Median follow-up time for infused patients was 12.17 months (IQR 5.53,22.73). The overall (complete + partial) response rate (ORR,CR + PR) after bridging was 41% for PMBCL and 28% for other LBCL, p = 0.0102. Thirty days ORR was 78% (53/68) with 50% (34) CR in PMBCL, and 75% (141/187) with 53% (100) CR in other LBCL, p = 0.5457. Ninety days ORR was 69% (45/65) with 65% (42) CR in PMBCL, and 54% (87/162) with 47% (76) CR in other LBCL; progressive disease was 21% in PMBCL and 45% in other LBCL, p = 0.0336. Twelve months progression-free survival was 62% (95% CI: 51–75) in PMBCL versus 48% (95% CI: 41–57) in other LBCL, p = 0.0386. Twelve months overall survival was 86% (95% CI: 78–95) in PMBCL versus 71% (95% CI: 64–79) in other LBCL, p = 0.0034. All grade cytokine release syndrome was 88% (228/260); all grade neurotoxicity was 34% (88/260), with 6% of fatal events in PMBCL. Non-relapse mortality was 3%. In conclusion, PMBCLs achieved significantly better response and survival rates than other LBCLs.
Published: 2024

4. PI-07: THE INTERNATIONAL HEMOGLOBINOPATHY RESEARCH NETWORK (INHERENT): AN INTERNATIONAL INITIATVE TO STUDY THE ROLE OF GENETIC MODIFIERS IN HEMOGLOBINOPATHIES

Author: KOUNTOURIS P., STEPHANOU C., ARCHER N., BONIFAZI F., GIANNUZZI V., KUO K., MAGGIO A., MAKANI J., MAÑÚ PEREIRA M., MICHAILIDOU K., NKYA S., NNODU O., TROMPETER S., TSHILOLO L., WONKAM A., ZILFALIL B., INUSA B., and KLEANTHOUS M.
Subjects: Diseases of the blood and blood-forming organs, RC633-647.5
Published: 2022
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5. Nilotinib in steroid-refractory cGVHD: prospective parallel evaluation of response, according to NIH criteria and exploratory response criteria (GITMO criteria)

Author: Olivieri, A., Mancini, G., Olivieri, J., Marinelli Busilacchi, E., Cimminiello, M., Pascale, S. P., Nuccorini, R., Patriarca, F., Corradini, P., Bacigalupo, A., Angelini, S., Poloni, A., Grillo, G., Onida, F., Martino, M., Di Renzo, N., Nagler, A., Mordini, N., Bruno, B., Ciceri, F., and Bonifazi, F.
Published: 2020
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6. Integrating biological HLA-DPB1 mismatch models to predict survival after unrelated hematopoietic cell transplantation

Author: Ruggeri, A, de Wreede, L, Muller, C, Crivello, P, Bonneville, E, Petersdorf, E, Socie, G, Dubois, V, Niittyvuopio, R, Perasaari, J, Yakoub-Agha, I, Cornelissen, J, Wieten, L, Gedde-Dahl, T, Forcade, E, Crawley, C, Marsh, S, Gandemer, V, Tholouli, E, Bulabois, C, Huynh, A, Choi, G, Deconinck, E, Itala-Remes, M, Lenhoff, S, Bengtsson, M, Johansson, J, van Gorkom, G, Hoogenboom, J, Vago, L, Rocha, V, Bonini, C, Chabannon, C, Fleischhauer, K, Clausen, J, Holter, W, Kalhs, P, Beguin, Y, Bron, D, Deeren, D, Lung, W, Kerre, T, Poire, X, Selleslag, D, Schroyens, W, Jindra, P, Mayer, J, Vydra, J, Zak, P, Nielsen, B, Sengeloev, H, Kaare, A, Partanen, A, Bay, J, Bertrand, Y, Blaise, D, Bourhis, J, Chevallier, P, Cluzeau, T, Damaj, G, Fegueux, N, Guyotat, D, Hunault-Berger, M, Labussiere-Wallet, H, Leleu, X, Lioure, B, Maury, S, Michel, G, Mohty, M, Rubio, M, Tilly, H, Turlure, P, Bethge, W, Casper, J, Einsele, H, Ganser, A, Kroger, N, Martin, S, Platzbecker, U, Reinhardt, C, Schafer-Eckart, K, Thurner, L, Valerius, T, Wulf, G, Karakasis, D, Spyridonidis, A, Hauser, P, Remenyi, P, Reykdal, S, Mousavi, A, Angelucci, E, Arcese, W, Benedetti, F, Bernasconi, P, Biondi, A, Bonifazi, F, Carella, A, Carluccio, P, Casini, M, Cavanna, L, Ciceri, F, Cimino, G, Corradini, P, Fanin, R, Galieni, P, Grillo, G, Iori, A, La Nasa, G, Locatelli, F, Marotta, G, Martino, M, Mazza, P, Mordini, N, Musso, M, Olivieri, A, Pavone, V, Pane, F, Petrini, M, Pioltelli, P, Rambaldi, A, Ruggeri, M, Saccardi, R, Santarone, S, Scime, R, Sica, S, Tarella, C, Velardi, A, Visani, G, Zecca, M, Tanase, A, Kulagin, A, Savchenko, V, Lopez, C, Amor, A, Lopez, J, Caballero, D, Duarte, R, Cascon, M, Porras, R, Perez-Simon, J, Rovira, M, Sanz, J, Carrete, J, Cammenga, J, Isaksson, C, Mielke, S, Chalandon, Y, Passweg, J, Schanz, U, Meijer, E, Kuball, J, Veelken, J, Apperley, J, Bloor, A, Byrne, J, Carpenter, B, Clark, A, Collin, M, Craddock, C, Gibson, B, Khan, A, Martin, M, Medd, P, Nicholson, E, Orchard, K, Patel, A, Peniket, A, Potter, V, Snowden, J, Wilson, K, Ruggeri A., de Wreede L. C., Muller C. R., Crivello P., Bonneville E. F., Petersdorf E. W., Socie G., Dubois V., Niittyvuopio R., Perasaari J., Yakoub-Agha I., Cornelissen J. J., Wieten L., Gedde-Dahl T., Forcade E., Crawley C. R., Marsh S. G. E., Gandemer V., Tholouli E., Bulabois C. -E., Huynh A., Choi G., Deconinck E., Itala-Remes M., Lenhoff S., Bengtsson M., Johansson J. -E., van Gorkom G., Hoogenboom J. D., Vago L., Rocha V., Bonini C., Chabannon C., Fleischhauer K., Clausen J., Holter W., Kalhs P., Beguin Y., Bron D., Deeren D., Lung W. K., Kerre T., Poire X., Selleslag D., Schroyens W., Jindra P., Mayer J., Vydra J., Zak P., Nielsen B., Sengeloev H., Kaare A., Partanen A., Bay J., Bertrand Y., Blaise D., Bourhis J. H., Chevallier P., Cluzeau T., Damaj G., Fegueux N., Guyotat D., Hunault-Berger M., Labussiere-Wallet H., Leleu X., Lioure B., Maury S., Michel G., Mohty M., Rubio M. T., Tilly H., Turlure P., Bethge W., Casper J., Einsele H., Ganser A., Kroger N., Martin S., Platzbecker U., Reinhardt C., Schafer-Eckart K., Thurner L., Valerius T., Wulf G. G., Karakasis D., Spyridonidis A., Hauser P., Remenyi P., Reykdal S., Mousavi A., Angelucci E., Arcese W., Benedetti F., Bernasconi P., Biondi A., Bonifazi F., Carella A. M., Carluccio P., Casini M., Cavanna L., Ciceri F., Cimino G., Corradini P., Fanin R., Galieni P., Grillo G., Iori A. P., La Nasa G., Locatelli F., Marotta G., Martino M., Mazza P., Mordini N., Musso M., Olivieri A., Pavone V., Pane F., Petrini M., Pioltelli P., Rambaldi A., Ruggeri M., Saccardi R., Santarone S., Scime R., Sica S., Tarella C., Velardi A., Visani G., Zecca M., Tanase A., Kulagin A., Savchenko V., Lopez C. A., Amor A. A., Lopez J. L. B., Caballero D., Duarte R., Cascon M. J. P., Porras R. P., Perez-Simon J. A., Rovira M., Sanz J., Carrete J. P. T., Cammenga J., Isaksson C., Mielke S., Chalandon Y., Passweg J., Schanz U., Meijer E., Kuball J., Veelken J. H., Apperley J., Bloor A., Byrne J., Carpenter B., Clark A., Collin M., Craddock C., Gibson B. E., Khan A., Martin M., Medd P., Nicholson E., Orchard K., Patel A., Peniket A., Potter V., Snowden J., Wilson K. M. O., Ruggeri, A, de Wreede, L, Muller, C, Crivello, P, Bonneville, E, Petersdorf, E, Socie, G, Dubois, V, Niittyvuopio, R, Perasaari, J, Yakoub-Agha, I, Cornelissen, J, Wieten, L, Gedde-Dahl, T, Forcade, E, Crawley, C, Marsh, S, Gandemer, V, Tholouli, E, Bulabois, C, Huynh, A, Choi, G, Deconinck, E, Itala-Remes, M, Lenhoff, S, Bengtsson, M, Johansson, J, van Gorkom, G, Hoogenboom, J, Vago, L, Rocha, V, Bonini, C, Chabannon, C, Fleischhauer, K, Clausen, J, Holter, W, Kalhs, P, Beguin, Y, Bron, D, Deeren, D, Lung, W, Kerre, T, Poire, X, Selleslag, D, Schroyens, W, Jindra, P, Mayer, J, Vydra, J, Zak, P, Nielsen, B, Sengeloev, H, Kaare, A, Partanen, A, Bay, J, Bertrand, Y, Blaise, D, Bourhis, J, Chevallier, P, Cluzeau, T, Damaj, G, Fegueux, N, Guyotat, D, Hunault-Berger, M, Labussiere-Wallet, H, Leleu, X, Lioure, B, Maury, S, Michel, G, Mohty, M, Rubio, M, Tilly, H, Turlure, P, Bethge, W, Casper, J, Einsele, H, Ganser, A, Kroger, N, Martin, S, Platzbecker, U, Reinhardt, C, Schafer-Eckart, K, Thurner, L, Valerius, T, Wulf, G, Karakasis, D, Spyridonidis, A, Hauser, P, Remenyi, P, Reykdal, S, Mousavi, A, Angelucci, E, Arcese, W, Benedetti, F, Bernasconi, P, Biondi, A, Bonifazi, F, Carella, A, Carluccio, P, Casini, M, Cavanna, L, Ciceri, F, Cimino, G, Corradini, P, Fanin, R, Galieni, P, Grillo, G, Iori, A, La Nasa, G, Locatelli, F, Marotta, G, Martino, M, Mazza, P, Mordini, N, Musso, M, Olivieri, A, Pavone, V, Pane, F, Petrini, M, Pioltelli, P, Rambaldi, A, Ruggeri, M, Saccardi, R, Santarone, S, Scime, R, Sica, S, Tarella, C, Velardi, A, Visani, G, Zecca, M, Tanase, A, Kulagin, A, Savchenko, V, Lopez, C, Amor, A, Lopez, J, Caballero, D, Duarte, R, Cascon, M, Porras, R, Perez-Simon, J, Rovira, M, Sanz, J, Carrete, J, Cammenga, J, Isaksson, C, Mielke, S, Chalandon, Y, Passweg, J, Schanz, U, Meijer, E, Kuball, J, Veelken, J, Apperley, J, Bloor, A, Byrne, J, Carpenter, B, Clark, A, Collin, M, Craddock, C, Gibson, B, Khan, A, Martin, M, Medd, P, Nicholson, E, Orchard, K, Patel, A, Peniket, A, Potter, V, Snowden, J, Wilson, K, Ruggeri A., de Wreede L. C., Muller C. R., Crivello P., Bonneville E. F., Petersdorf E. W., Socie G., Dubois V., Niittyvuopio R., Perasaari J., Yakoub-Agha I., Cornelissen J. J., Wieten L., Gedde-Dahl T., Forcade E., Crawley C. R., Marsh S. G. E., Gandemer V., Tholouli E., Bulabois C. -E., Huynh A., Choi G., Deconinck E., Itala-Remes M., Lenhoff S., Bengtsson M., Johansson J. -E., van Gorkom G., Hoogenboom J. D., Vago L., Rocha V., Bonini C., Chabannon C., Fleischhauer K., Clausen J., Holter W., Kalhs P., Beguin Y., Bron D., Deeren D., Lung W. K., Kerre T., Poire X., Selleslag D., Schroyens W., Jindra P., Mayer J., Vydra J., Zak P., Nielsen B., Sengeloev H., Kaare A., Partanen A., Bay J., Bertrand Y., Blaise D., Bourhis J. H., Chevallier P., Cluzeau T., Damaj G., Fegueux N., Guyotat D., Hunault-Berger M., Labussiere-Wallet H., Leleu X., Lioure B., Maury S., Michel G., Mohty M., Rubio M. T., Tilly H., Turlure P., Bethge W., Casper J., Einsele H., Ganser A., Kroger N., Martin S., Platzbecker U., Reinhardt C., Schafer-Eckart K., Thurner L., Valerius T., Wulf G. G., Karakasis D., Spyridonidis A., Hauser P., Remenyi P., Reykdal S., Mousavi A., Angelucci E., Arcese W., Benedetti F., Bernasconi P., Biondi A., Bonifazi F., Carella A. M., Carluccio P., Casini M., Cavanna L., Ciceri F., Cimino G., Corradini P., Fanin R., Galieni P., Grillo G., Iori A. P., La Nasa G., Locatelli F., Marotta G., Martino M., Mazza P., Mordini N., Musso M., Olivieri A., Pavone V., Pane F., Petrini M., Pioltelli P., Rambaldi A., Ruggeri M., Saccardi R., Santarone S., Scime R., Sica S., Tarella C., Velardi A., Visani G., Zecca M., Tanase A., Kulagin A., Savchenko V., Lopez C. A., Amor A. A., Lopez J. L. B., Caballero D., Duarte R., Cascon M. J. P., Porras R. P., Perez-Simon J. A., Rovira M., Sanz J., Carrete J. P. T., Cammenga J., Isaksson C., Mielke S., Chalandon Y., Passweg J., Schanz U., Meijer E., Kuball J., Veelken J. H., Apperley J., Bloor A., Byrne J., Carpenter B., Clark A., Collin M., Craddock C., Gibson B. E., Khan A., Martin M., Medd P., Nicholson E., Orchard K., Patel A., Peniket A., Potter V., Snowden J., and Wilson K. M. O.
Published: 2023

7. The Italian CART‐SIE real life multicenter observational study on Chimeric Antigen Receptor T‐cell (CAR‐T) therapy for large B‐cell (LBCL) and mantle cell (MCL) lymphomas

Author: Chiappella, A., primary, Dodero, A., additional, Ljevar, S., additional, Pennisi, M., additional, Bonifazi, F., additional, De Philippis, C., additional, Galli, E., additional, Di Rocco, A., additional, Tisi, M. C., additional, Cutini, I., additional, Carrabba, M. G., additional, Musso, M., additional, Martino, M., additional, Barbui, A. M., additional, Botto, B., additional, Farina, M., additional, Grillo, G., additional, Patriarca, F., additional, Ladetto, M., additional, Arcaini, L., additional, Bermema, A., additional, Miceli, R., additional, Magni, M., additional, Zinzani, P. L., additional, Bramanti, S., additional, Chiusolo, P., additional, Martelli, M., additional, Carniti, C., additional, and Corradini, P., additional
Published: 2023
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8. Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018

Author: Sultana, J, Crisafulli, S, Almas, M, Antonazzo, I, Baan, E, Bartolini, C, Bertuccio, M, Bonifazi, F, Capuano, A, Didio, A, Ehrenstein, V, Felisi, M, Ferrajolo, C, Fontana, A, Francisca, R, Fourrier-Reglat, A, Fortuny, J, Gini, R, Hyeraci, G, Hoeve, C, Kontogiorgis, C, Isgro, V, Lalagkas, P, L'Abbate, L, Layton, D, Landi, A, Narduzzi, S, Roque Pereira, L, Poulentzas, G, Rafaniello, C, Roberto, G, Scondotto, G, Sportiello, L, Toma, M, Toussi, M, Verhamme, K, Volpe, E, Trifiro, G, Sultana J., Crisafulli S., Almas M., Antonazzo I. C., Baan E., Bartolini C., Bertuccio M. P., Bonifazi F., Capuano A., Didio A., Ehrenstein V., Felisi M., Ferrajolo C., Fontana A., Francisca R., Fourrier-Reglat A., Fortuny J., Gini R., Hyeraci G., Hoeve C., Kontogiorgis C., Isgro V., Lalagkas P. -N., L'Abbate L., Layton D., Landi A., Narduzzi S., Roque Pereira L., Poulentzas G., Rafaniello C., Roberto G., Scondotto G., Sportiello L., Toma M., Toussi M., Verhamme K., Volpe E., Trifiro G., Sultana, J, Crisafulli, S, Almas, M, Antonazzo, I, Baan, E, Bartolini, C, Bertuccio, M, Bonifazi, F, Capuano, A, Didio, A, Ehrenstein, V, Felisi, M, Ferrajolo, C, Fontana, A, Francisca, R, Fourrier-Reglat, A, Fortuny, J, Gini, R, Hyeraci, G, Hoeve, C, Kontogiorgis, C, Isgro, V, Lalagkas, P, L'Abbate, L, Layton, D, Landi, A, Narduzzi, S, Roque Pereira, L, Poulentzas, G, Rafaniello, C, Roberto, G, Scondotto, G, Sportiello, L, Toma, M, Toussi, M, Verhamme, K, Volpe, E, Trifiro, G, Sultana J., Crisafulli S., Almas M., Antonazzo I. C., Baan E., Bartolini C., Bertuccio M. P., Bonifazi F., Capuano A., Didio A., Ehrenstein V., Felisi M., Ferrajolo C., Fontana A., Francisca R., Fourrier-Reglat A., Fortuny J., Gini R., Hyeraci G., Hoeve C., Kontogiorgis C., Isgro V., Lalagkas P. -N., L'Abbate L., Layton D., Landi A., Narduzzi S., Roque Pereira L., Poulentzas G., Rafaniello C., Roberto G., Scondotto G., Sportiello L., Toma M., Toussi M., Verhamme K., Volpe E., and Trifiro G.
Abstract: Background: The European post-authorisation study (EU PAS) register is a repository launched in 2010 by the European Medicines Agency (EMA). All EMA-requested PAS, commonly observational studies, must be recorded in this register. Multi-database studies (MDS) leveraging secondary data have become an important strategy to conduct PAS in recent years, as reflected by the type of studies registered in the EU PAS register. Objectives: To analyse and describe PAS in the EU PAS register, with focus on MDS. Methods: Studies in the EU PAS register from inception to 31st December 2018 were described concerning transparency, regulatory obligations, scope, study type (e.g., observational study, clinical trial, survey, systematic review/meta-analysis), study design, type of data collection and target population. MDS were defined as studies conducted through secondary use of >1 data source not linked at patient-level. Data extraction was carried out independently by 14 centres with expertise in pharmacoepidemiology, using publicly available information in the EU PAS register including study protocol, whenever available, using a standardised data collection form. For validation purposes, a second revision of key fields for a 15% random sample of studies was carried out by a different centre. The inter-rater reliability (IRR) was then calculated. Finally, to identify predictors of primary data collection-based studies/versus those based on secondary use of healthcare databases) or MDS (vs. non-MDS), odds ratios (OR) and 95% confidence intervals (CI) were calculated fitting univariate logistic regression models. Results: Overall, 1426 studies were identified. Clinical trials (N = 30; 2%), systematic reviews/meta-analyses (N = 16; 1%) and miscellaneous study designs (N = 46; 3%) were much less common than observational studies (N = 1227; 86%). The protocol was available for 63% (N = 360) of 572 observational studies requested by a competent authority. Overall, 36% (N = 446) of ob
Published: 2022

9. ‘Real-life’ report on the management of chronic GvHD in the Gruppo Italiano Trapianto Midollo Osseo (GITMO)

Author: Giaccone, L, Mancini, G, Mordini, N, Gargiulo, G, De Cecco, V, Angelini, S, Arpinati, M, Baronciani, D, Bozzoli, V, Bramanti, S, Calore, E, Cavattoni, I M, Cimminiello, M, Colombo, A A, Facchini, L, Falcioni, S, Faraci, M, Fedele, R, Guidi, S, Iori, A P, Marotta, S, Micò, M C, Milone, G, Onida, F, Pastore, D, Patriarca, F, Pini, M, Raimondi, R, Rovelli, A, Santarone, S, Severino, A, Skert, C, Stanghellini, M T L, Tecchio, C, Vassallo, E, Chiarucci, M, Bruno, B, Bonifazi, F, and Olivieri, A
Published: 2018
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10. Integrating biological HLA-DPB1 mismatch models to predict survival after unrelated hematopoietic cell transplantation

Author: Ruggeri, A., de Wreede, L. C., Muller, C. R., Crivello, P., Bonneville, E. F., Petersdorf, E. W., Socie, G., Dubois, V., Niittyvuopio, R., Perasaari, J., Yakoub-Agha, I., Cornelissen, J. J., Wieten, L., Gedde-Dahl, T., Forcade, E., Crawley, C. R., Marsh, S. G. E., Gandemer, V., Tholouli, E., Bulabois, C. -E., Huynh, A., Choi, G., Deconinck, E., Itala-Remes, M., Lenhoff, S., Bengtsson, M., Johansson, J. -E., van Gorkom, G., Hoogenboom, J. D., Vago, L., Rocha, V., Bonini, C., Chabannon, C., Fleischhauer, K., Clausen, J., Holter, W., Kalhs, P., Beguin, Y., Bron, D., Deeren, D., Lung, W. K., Kerre, T., Poire, X., Selleslag, D., Schroyens, W., Jindra, P., Mayer, J., Vydra, J., Zak, P., Nielsen, B., Sengeloev, H., Kaare, A., Partanen, A., Bay, J., Bertrand, Y., Blaise, D., Bourhis, J. H., Chevallier, P., Cluzeau, T., Damaj, G., Fegueux, N., Guyotat, D., Hunault-Berger, M., Labussiere-Wallet, H., Leleu, X., Lioure, B., Maury, S., Michel, G., Mohty, M., Rubio, M. T., Tilly, H., Turlure, P., Bethge, W., Casper, J., Einsele, H., Ganser, A., Kroger, N., Martin, S., Platzbecker, U., Reinhardt, C., Schafer-Eckart, K., Thurner, L., Valerius, T., Wulf, G. G., Karakasis, D., Spyridonidis, A., Hauser, P., Remenyi, P., Reykdal, S., Mousavi, A., Angelucci, E., Arcese, W., Benedetti, F., Bernasconi, P., Biondi, A., Bonifazi, F., Carella, A. M., Carluccio, P., Casini, M., Cavanna, L., Ciceri, F., Cimino, G., Corradini, P., Fanin, R., Galieni, P., Grillo, G., Iori, A. P., La Nasa, G., Locatelli, Franco, Marotta, G., Martino, M., Mazza, P., Mordini, N., Musso, M., Olivieri, A., Pavone, V., Pane, F., Petrini, M., Pioltelli, P., Rambaldi, A., Ruggeri, M., Saccardi, R., Santarone, S., Scime, R., Sica, S., Tarella, C., Velardi, A., Visani, G., Zecca, M., Tanase, A., Kulagin, A., Savchenko, V., Lopez, C. A., Amor, A. A., Lopez, J. L. B., Caballero, D., Duarte, R., Cascon, M. J. P., Porras, R. P., Perez-Simon, J. A., Rovira, M., Sanz, J., Carrete, J. P. T., Cammenga, J., Isaksson, C., Mielke, S., Chalandon, Y., Passweg, J., Schanz, U., Meijer, E., Kuball, J., Veelken, J. H., Apperley, J., Bloor, A., Byrne, J., Carpenter, B., Clark, A., Collin, M., Craddock, C., Gibson, B. E., Khan, A., Martin, M., Medd, P., Nicholson, E., Orchard, K., Patel, A., Peniket, A., Potter, V., Snowden, J., Wilson, K. M. O., Locatelli F. (ORCID:0000-0002-7976-3654), Ruggeri, A., de Wreede, L. C., Muller, C. R., Crivello, P., Bonneville, E. F., Petersdorf, E. W., Socie, G., Dubois, V., Niittyvuopio, R., Perasaari, J., Yakoub-Agha, I., Cornelissen, J. J., Wieten, L., Gedde-Dahl, T., Forcade, E., Crawley, C. R., Marsh, S. G. E., Gandemer, V., Tholouli, E., Bulabois, C. -E., Huynh, A., Choi, G., Deconinck, E., Itala-Remes, M., Lenhoff, S., Bengtsson, M., Johansson, J. -E., van Gorkom, G., Hoogenboom, J. D., Vago, L., Rocha, V., Bonini, C., Chabannon, C., Fleischhauer, K., Clausen, J., Holter, W., Kalhs, P., Beguin, Y., Bron, D., Deeren, D., Lung, W. K., Kerre, T., Poire, X., Selleslag, D., Schroyens, W., Jindra, P., Mayer, J., Vydra, J., Zak, P., Nielsen, B., Sengeloev, H., Kaare, A., Partanen, A., Bay, J., Bertrand, Y., Blaise, D., Bourhis, J. H., Chevallier, P., Cluzeau, T., Damaj, G., Fegueux, N., Guyotat, D., Hunault-Berger, M., Labussiere-Wallet, H., Leleu, X., Lioure, B., Maury, S., Michel, G., Mohty, M., Rubio, M. T., Tilly, H., Turlure, P., Bethge, W., Casper, J., Einsele, H., Ganser, A., Kroger, N., Martin, S., Platzbecker, U., Reinhardt, C., Schafer-Eckart, K., Thurner, L., Valerius, T., Wulf, G. G., Karakasis, D., Spyridonidis, A., Hauser, P., Remenyi, P., Reykdal, S., Mousavi, A., Angelucci, E., Arcese, W., Benedetti, F., Bernasconi, P., Biondi, A., Bonifazi, F., Carella, A. M., Carluccio, P., Casini, M., Cavanna, L., Ciceri, F., Cimino, G., Corradini, P., Fanin, R., Galieni, P., Grillo, G., Iori, A. P., La Nasa, G., Locatelli, Franco, Marotta, G., Martino, M., Mazza, P., Mordini, N., Musso, M., Olivieri, A., Pavone, V., Pane, F., Petrini, M., Pioltelli, P., Rambaldi, A., Ruggeri, M., Saccardi, R., Santarone, S., Scime, R., Sica, S., Tarella, C., Velardi, A., Visani, G., Zecca, M., Tanase, A., Kulagin, A., Savchenko, V., Lopez, C. A., Amor, A. A., Lopez, J. L. B., Caballero, D., Duarte, R., Cascon, M. J. P., Porras, R. P., Perez-Simon, J. A., Rovira, M., Sanz, J., Carrete, J. P. T., Cammenga, J., Isaksson, C., Mielke, S., Chalandon, Y., Passweg, J., Schanz, U., Meijer, E., Kuball, J., Veelken, J. H., Apperley, J., Bloor, A., Byrne, J., Carpenter, B., Clark, A., Collin, M., Craddock, C., Gibson, B. E., Khan, A., Martin, M., Medd, P., Nicholson, E., Orchard, K., Patel, A., Peniket, A., Potter, V., Snowden, J., Wilson, K. M. O., and Locatelli F. (ORCID:0000-0002-7976-3654)
Abstract: NO ABSTRACT
Published: 2023

11. Busulfan or Treosulfan Conditioning Platform for Allogeneic Stem Cell Transplantation in Patients Aged >60 y with Acute Myeloid Leukemia/Myelodysplastic Syndrome: A Subanalysis of the GITMO AlloEld Study

Author: Malagola, M., Polverelli, N., Martino, Michelangelo, Patriarca, Fabrizio, Bruno, Brunella, Giaccone, L., Grillo, G., Bramanti, S., Bernasconi, P., De Gobbi, M., Natale, A., Terruzzi, E., Olivieri, Alessandra, Chiusolo, Patrizia, Carella, A. M., Casini, Marina, Maffini, E., Nozzoli, C., Mazza, P., Bassi, S., Onida, F., Vacca, Alessandro, Falcioni, S., Luppi, M., Iori, A. P., Pavone, V., Skert, C., Carluccio, P., Borghero, C., Proia, A., Selleri, C., Rubini, V., Sacchi, N., Oldani, E., Bonifazi, F., Ciceri, F., Russo, Daniele, Bernardi, S., Farina, M., Fiore, M., Lupo Stanghellini, M. T., Fanin, R., Faraci, D. G., Castagna, Luigi, Colombo, A. A., Nicoli, P., Santarone, S., Scortechini, I., Metafuni, Elisabetta, Merla, E., Cavattoni, I., Cutini, I., Mazzone, A., Saporiti, G., Canale, F. A., Piras, Edoardo, Galieni, P., Debbia, G., La Rocca, U., Mele, Dario Antonio, Carobolante, F., Elice, F., Fanelli, F., Martino M., Patriarca F., Bruno B., Olivieri A., Chiusolo P. (ORCID:0000-0002-1355-1587), Casini M. (ORCID:0000-0002-3209-7770), Vacca A., Russo D., Castagna L., Metafuni E., Piras E., Mele A., Malagola, M., Polverelli, N., Martino, Michelangelo, Patriarca, Fabrizio, Bruno, Brunella, Giaccone, L., Grillo, G., Bramanti, S., Bernasconi, P., De Gobbi, M., Natale, A., Terruzzi, E., Olivieri, Alessandra, Chiusolo, Patrizia, Carella, A. M., Casini, Marina, Maffini, E., Nozzoli, C., Mazza, P., Bassi, S., Onida, F., Vacca, Alessandro, Falcioni, S., Luppi, M., Iori, A. P., Pavone, V., Skert, C., Carluccio, P., Borghero, C., Proia, A., Selleri, C., Rubini, V., Sacchi, N., Oldani, E., Bonifazi, F., Ciceri, F., Russo, Daniele, Bernardi, S., Farina, M., Fiore, M., Lupo Stanghellini, M. T., Fanin, R., Faraci, D. G., Castagna, Luigi, Colombo, A. A., Nicoli, P., Santarone, S., Scortechini, I., Metafuni, Elisabetta, Merla, E., Cavattoni, I., Cutini, I., Mazzone, A., Saporiti, G., Canale, F. A., Piras, Edoardo, Galieni, P., Debbia, G., La Rocca, U., Mele, Dario Antonio, Carobolante, F., Elice, F., Fanelli, F., Martino M., Patriarca F., Bruno B., Olivieri A., Chiusolo P. (ORCID:0000-0002-1355-1587), Casini M. (ORCID:0000-0002-3209-7770), Vacca A., Russo D., Castagna L., Metafuni E., Piras E., and Mele A.
Abstract: Background. The conditioning regimens with different alkylators at different doses can influence the outcome of allogeneic stem cell transplantation (SCT), but conclusive data are missing. Methods. With the aim to analyze real-life allogeneic SCTs performed in Italy between 2006 and 2017 in elderly patients (aged >60 y) with acute myeloid leukemia or myelodysplastic syndrome, we collected 780 first transplants data. For analysis purposes, patients were grouped according to the type of alkylator included in the conditioning (busulfan [BU]-based; n = 618; 79%; treosulfan [TREO]-based; n=162; 21%). Results. No significant differences were observed in nonrelapse mortality, cumulative incidence of relapse, and overall survival, although in the TREO-based group, we observed a greater proportion of elderly patients (P < 0.001); more active diseases at the time of SCT (P < 0.001); a higher prevalence of patients with either hematopoietic cell transplantation-comorbidity index ≥3 (P < 0.001) or a good Karnofsky performance status (P = 0.025); increased use of peripheral blood stem cells as graft sources (P < 0.001); and greater use of reduced intensity conditioning regimens (P = 0.013) and of haploidentical donors (P < 0.001). Moreover, the 2-y cumulative incidence of relapse with myeloablative doses of BU was significantly lower than that registered with reduced intensity conditioning (21% versus 31%; P = 0.0003). This was not observed in the TREO-based group. Conclusions. Despite a higher number of risk factors in the TREO group, no significant differences were observed in nonrelapse mortality, cumulative incidence of relapse, and overall survival according to the type of alkylator, suggesting that TREO has no advantage over BU in terms of efficacy and toxicity in acute myeloid leukemia and myelodysplastic syndrome.
Published: 2023

12. Decision analysis of allogeneic hematopoietic stem cell transplantation for patients with myelodysplastic syndrome stratified according to the revised International Prognostic Scoring System

Author: Della Porta, M G, Jackson, C H, Alessandrino, E P, Rossi, M, Bacigalupo, A, van Lint, M T, Bernardi, M, Allione, B, Bosi, A, Guidi, S, Santini, V, Malcovati, L, Ubezio, M, Milanesi, C, Todisco, E, Voso, M T, Musto, P, Onida, F, Iori, A P, Cerretti, R, Grillo, G, Molteni, A, Pioltelli, P, Borin, L, Angelucci, E, Oldani, E, Sica, S, Pascutto, C, Ferretti, V, Santoro, A, Bonifazi, F, Cazzola, M, and Rambaldi, A
Published: 2017
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13. Radioimmunotherapy-augmented BEAM chemotherapy vs BEAM alone as the high-dose regimen for autologous stem cell transplantation (ASCT) in relapsed follicular lymphoma (FL): a retrospective study of the EBMT Lymphoma Working Party

Author: Bento, L, Boumendil, A, Finel, H, Le Gouill, S, Amorim, S, Monjanel, H, Bouabdallah, R, Bay, J O, Nicolas-Virelizier, E, McQuaker, G, Rossi, G, Johnson, R, Huynh, A, Ceballos, P, Rambaldi, A, Bachy, E, Malladi, R, Orchard, K, Pohlreich, D, Tilly, H, Bonifazi, F, Poiré, X, Guilhot, F, Haenel, A, Crawley, C, Metzner, B, Gribben, J, Russell, N H, Damaj, G, Thomson, K, Dreger, P, and Montoto, S
Published: 2017
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14. Factors predicting outcome after allogeneic transplant in refractory acute myeloid leukemia: a retrospective analysis of Gruppo Italiano Trapianto di Midollo Osseo (GITMO)

Author: Todisco, E, Ciceri, F, Boschini, C, Giglio, F, Bacigalupo, A, Patriarca, F, Donnini, I, Alessandrino, E P, Arcese, W, Iori, A P, Marenco, P, Cavattoni, I, Chiusolo, P, Terruzzi, E, Castagna, L, Santoro, A, Bosi, A, Oldani, E, Bruno, B, Bonifazi, F, and Rambaldi, A
Published: 2017
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15. Autologous stem cell transplantation is still a valid option in good- and intermediate-risk AML: a GITMO survey on 809 patients autografted in first complete remission

Author: Saraceni, F, Bruno, B, Lemoli, R M, Meloni, G, Arcese, W, Falda, M, Ciceri, F, Alessandrino, E P, Specchia, G, Scimè, R, Raimondi, R, Bacigalupo, A, Bosi, A, Onida, F, Rambaldi, A, Bonifazi, F, and Olivieri, A
Published: 2017
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16. Changes in Stem Cell Transplant activity and procedures during SARS-CoV2 pandemic in Italy: an Italian Bone Marrow Transplant Group (GITMO) nationwide analysis (TransCOVID-19 Survey)

Author: Russo, D, Polverelli, N, Malagola, M, Farina, M, Leoni, A, Bernardi, S, Mammoliti, S, Sacchi, N, Martino, M, Ciceri, F, Zallio, F, Olivieri, A, Falcioni, S, Storti, G, Michieli, M, Carluccio, P, Grassi, A, Oldani, E, Bonifazi, F, Prete, A, Cavattoni, I, Maffeis, M, Pastore, D, Vacca, A, Caravelli, D, Mirabile, M, Mordini, N, Nozzoli, C, Faraci, M, Federico, V, Ronconi, S, Skert, C, Onida, F, Marcatti, M, Piemontese, S, Narni, F, Balduzzi, A, De Simone, G, Picardi, A, De Gobbi, M, Calore, E, Tringali, S, Zecca, M, Secondino, S, Guiducci, B, Pelosini, M, Zuffa, E, Facchini, L, Imola, M, Iori, A, Proia, A, Sica, S, Armiento, D, Carella, A, Dellacasa, C, Fagioli, F, Rabusin, M, Ferrario, A, Elice, F, Russo D., Polverelli N., Malagola M., Farina M., Leoni A., Bernardi S., Mammoliti S., Sacchi N., Martino M., Ciceri F., Zallio F., Olivieri A., Falcioni S., Storti G., Michieli M., Carluccio P., Grassi A., Oldani E., Bonifazi F., Prete A., Cavattoni I. M., Maffeis M., Pastore D., Vacca A., Caravelli D., Mirabile M., Mordini N., Nozzoli C., Faraci M., Federico V., Ronconi S., Skert C., Onida F., Marcatti M., Piemontese S., Narni F., Balduzzi A., De Simone G., Picardi A., De Gobbi M., Calore E., Tringali S., Zecca M., Secondino S., Guiducci B., Pelosini M., Zuffa E., Facchini L., Imola M., Iori A. P., Proia A., Sica S., Armiento D., Carella A. M., Dellacasa C. M., Fagioli F., Rabusin M., Ferrario A., Elice F., Russo, D, Polverelli, N, Malagola, M, Farina, M, Leoni, A, Bernardi, S, Mammoliti, S, Sacchi, N, Martino, M, Ciceri, F, Zallio, F, Olivieri, A, Falcioni, S, Storti, G, Michieli, M, Carluccio, P, Grassi, A, Oldani, E, Bonifazi, F, Prete, A, Cavattoni, I, Maffeis, M, Pastore, D, Vacca, A, Caravelli, D, Mirabile, M, Mordini, N, Nozzoli, C, Faraci, M, Federico, V, Ronconi, S, Skert, C, Onida, F, Marcatti, M, Piemontese, S, Narni, F, Balduzzi, A, De Simone, G, Picardi, A, De Gobbi, M, Calore, E, Tringali, S, Zecca, M, Secondino, S, Guiducci, B, Pelosini, M, Zuffa, E, Facchini, L, Imola, M, Iori, A, Proia, A, Sica, S, Armiento, D, Carella, A, Dellacasa, C, Fagioli, F, Rabusin, M, Ferrario, A, Elice, F, Russo D., Polverelli N., Malagola M., Farina M., Leoni A., Bernardi S., Mammoliti S., Sacchi N., Martino M., Ciceri F., Zallio F., Olivieri A., Falcioni S., Storti G., Michieli M., Carluccio P., Grassi A., Oldani E., Bonifazi F., Prete A., Cavattoni I. M., Maffeis M., Pastore D., Vacca A., Caravelli D., Mirabile M., Mordini N., Nozzoli C., Faraci M., Federico V., Ronconi S., Skert C., Onida F., Marcatti M., Piemontese S., Narni F., Balduzzi A., De Simone G., Picardi A., De Gobbi M., Calore E., Tringali S., Zecca M., Secondino S., Guiducci B., Pelosini M., Zuffa E., Facchini L., Imola M., Iori A. P., Proia A., Sica S., Armiento D., Carella A. M., Dellacasa C. M., Fagioli F., Rabusin M., Ferrario A., and Elice F.
Abstract: The Transplant Centers belonging to Gruppo Italiano per il Trapianto di Midollo Osseo (GITMO) conducted a survey with the aim of evaluating the effect of SARS-CoV2 pandemic on the allogeneic transplant activity in Italy. The pandemic period from 1/3/2020 to 31/7/2020 was compared with the same period in 2019. Overall, in 2020 there was a 2.4% reduction in the number of allo-HCT cases compared to 2019. Interestingly, this deflection did not affect the acute leukemia cases (+5.7% in 2020). The use of peripheral blood-derived stem cells (+10.7%) and cryopreservation (97.4% of the centers) was highly adopted in 2020. Despite the sanitary emergency, almost all of the surveyed centers declared no impact of SARS-CoV2 pandemic on the transplant timing and outcomes, and the sanitary policy was positively evaluated by the majority of centers. The emergency measures ensured that only a minority of the allo-HCT patients had been infected by SARS-CoV2; however, a mortality of 42.1% among the allo-HCT patients hospitalized for COVID-19 was recorded. This survey gives us the information that the GITMO Group reacted positively to the pandemic. Thanks to the emergency strategies, the Italian allo-HCT activity continued safely, showing only a minor deflection and offering the same probability of cure to the transplanted patients.
Published: 2021

17. RItA: The Italian severe/uncontrolled asthma registry

Author: Maio, S., Baldacci, S., Bresciani, M., Simoni, M., Latorre, M., Murgia, N., Spinozzi, F., Braschi, M., Antonicelli, L., Brunetto, B., Iacovacci, P., Roazzi, P., Pini, C., Pata, M., La Grasta, L., Paggiaro, P., Viegi, G., Angino, A., Carrozzi, L., Cerrai, S., Di Pede, F., Martini, F., Pala, A.P., Pistelli, F., Sarno, G., Silvi, P., Novelli, F., Ferri, M., Bonifazi, F., and Viegi, G.
Published: 2018
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18. Allogeneic hematopoietic cell transplantation for multiple myeloma in Europe: trends and outcomes over 25 years. A study by the EBMT Chronic Malignancies Working Party

Author: Sobh, M, Michallet, M, Gahrton, G, Iacobelli, S, van Biezen, A, Schönland, S, Petersen, E, Schaap, N, Bonifazi, F, Volin, L, Meijer, E, Niederwieser, D, El-Cheikh, J, Tabrizi, R, Fegeux, N, Finke, J, Bunjes, D, Cornelissen, J, Einsele, H, Bruno, B, Potter, M, Fanin, R, Mohty, M, Garderet, L, and Kröger, N
Published: 2016
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19. Effect of gas—phase carbon depletion by sooting on the structure of methane/air flamelets

Author: Bonifazi, F. and Lentini, D.
Published: 2016
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20. Impact of conditioning with TBI in adult patients with T-cell ALL who receive a myeloablative allogeneic stem cell transplantation: a report from the acute leukemia working party of EBMT

Author: Cahu, X, Labopin, M, Giebel, S, Aljurf, M, Kyrcz-Krzemien, S, Socié, G, Eder, M, Bonifazi, F, Bunjes, D, Vigouroux, S, Michallet, M, Stelljes, M, Zuckerman, T, Finke, J, Passweg, J, Yakoub-Agha, I, Niederwieser, D, Sucak, G, Sengeløv, H, Polge, E, Nagler, A, Esteve, J, and Mohty, M
Published: 2016
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21. Changes in Stem Cell Transplant activity and procedures during SARS-CoV2 pandemic in Italy: an Italian Bone Marrow Transplant Group (GITMO) nationwide analysis (TransCOVID-19 Survey)

Author: Russo D., Polverelli N., Malagola M., Farina M., Leoni A., Bernardi S., Mammoliti S., Sacchi N., Martino M., Ciceri F., Zallio F., Olivieri A., Falcioni S., Storti G., Michieli M., Carluccio P., Grassi A., Oldani E., Bonifazi F., Prete A., Cavattoni I. M., Maffeis M., Pastore D., Vacca A., Caravelli D., Mirabile M., Mordini N., Nozzoli C., Faraci M., Federico V., Ronconi S., Skert C., Onida F., Marcatti M., Piemontese S., Narni F., Balduzzi A., De Simone G., Picardi A., De Gobbi M., Calore E., Tringali S., Zecca M., Secondino S., Guiducci B., Pelosini M., Zuffa E., Facchini L., Imola M., Iori A. P., Proia A., Sica S., Armiento D., Carella A. M., Dellacasa C. M., Fagioli F., Rabusin M., Ferrario A., Elice F., Russo, D, Polverelli, N, Malagola, M, Farina, M, Leoni, A, Bernardi, S, Mammoliti, S, Sacchi, N, Martino, M, Ciceri, F, Zallio, F, Olivieri, A, Falcioni, S, Storti, G, Michieli, M, Carluccio, P, Grassi, A, Oldani, E, Bonifazi, F, Prete, A, Cavattoni, I, Maffeis, M, Pastore, D, Vacca, A, Caravelli, D, Mirabile, M, Mordini, N, Nozzoli, C, Faraci, M, Federico, V, Ronconi, S, Skert, C, Onida, F, Marcatti, M, Piemontese, S, Narni, F, Balduzzi, A, De Simone, G, Picardi, A, De Gobbi, M, Calore, E, Tringali, S, Zecca, M, Secondino, S, Guiducci, B, Pelosini, M, Zuffa, E, Facchini, L, Imola, M, Iori, A, Proia, A, Sica, S, Armiento, D, Carella, A, Dellacasa, C, Fagioli, F, Rabusin, M, Ferrario, A, Elice, F, Russo, D., Polverelli, N., Malagola, M., Farina, M., Leoni, A., Bernardi, S., Mammoliti, S., Sacchi, N., Martino, M., Ciceri, F., Zallio, F., Olivieri, A., Falcioni, S., Storti, G., Michieli, M., Carluccio, P., Grassi, A., Oldani, E., Bonifazi, F., Prete, A., Cavattoni, I. M., Maffeis, M., Pastore, D., Vacca, A., Caravelli, D., Mirabile, M., Mordini, N., Nozzoli, C., Faraci, M., Federico, V., Ronconi, S., Skert, C., Onida, F., Marcatti, M., Piemontese, S., Narni, F., Balduzzi, A., De Simone, G., Picardi, A., De Gobbi, M., Calore, E., Tringali, S., Zecca, M., Secondino, S., Guiducci, B., Pelosini, M., Zuffa, E., Facchini, L., Imola, M., Iori, A. P., Proia, A., Sica, S., Armiento, D., Carella, A. M., Dellacasa, C. M., Fagioli, F., Rabusin, M., Ferrario, A., and Elice, F.
Subjects: Homologous, Myeloid, medicine.medical_specialty, 2019-20 coronavirus outbreak, Bone marrow transplant, Coronavirus disease 2019 (COVID-19), Epidemiology, medicine.medical_treatment, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Hematopoietic stem cell transplantation, Acute, Humans, Italy, Pandemics, RNA, Viral, SARS-CoV-2, Stem Cell Transplantation, Transplantation, Homologous, COVID-19, Hematopoietic Stem Cell Transplantation, Leukemia, Myeloid, Acute, Article, hematopoietic stem cell transplantation, covid-19, pandemic, Internal medicine, Pandemic, medicine, Viral, Acute leukemia, Transplantation, Leukemia, business.industry, Hematology, Stem-cell research, RNA, Stem cell, business
Abstract: The Transplant Centers belonging to Gruppo Italiano per il Trapianto di Midollo Osseo (GITMO) conducted a survey with the aim of evaluating the effect of SARS-CoV2 pandemic on the allogeneic transplant activity in Italy. The pandemic period from 1/3/2020 to 31/7/2020 was compared with the same period in 2019. Overall, in 2020 there was a 2.4% reduction in the number of allo-HCT cases compared to 2019. Interestingly, this deflection did not affect the acute leukemia cases (+5.7% in 2020). The use of peripheral blood-derived stem cells (+10.7%) and cryopreservation (97.4% of the centers) was highly adopted in 2020. Despite the sanitary emergency, almost all of the surveyed centers declared no impact of SARS-CoV2 pandemic on the transplant timing and outcomes, and the sanitary policy was positively evaluated by the majority of centers. The emergency measures ensured that only a minority of the allo-HCT patients had been infected by SARS-CoV2; however, a mortality of 42.1% among the allo-HCT patients hospitalized for COVID-19 was recorded. This survey gives us the information that the GITMO Group reacted positively to the pandemic. Thanks to the emergency strategies, the Italian allo-HCT activity continued safely, showing only a minor deflection and offering the same probability of cure to the transplanted patients.
Published: 2021

22. P1481: THE INTERNATIONAL HEMOGLOBINOPATHY RESEARCH NETWORK (INHERENT): AN INTERNATIONAL INITIATIVE TO STUDY THE ROLE OF GENETIC MODIFIERS IN HEMOGLOBINOPATHIES

Author: Kountouris, P., primary, Stephanou, C., additional, Archer, N., additional, Bonifazi, F., additional, Giannuzzi, V., additional, Kuo, K., additional, Maggio, A., additional, Makani, J., additional, Mañú Pereira, M. D. M., additional, Michailidou, K., additional, Nkya, S. W., additional, Nnodu, O., additional, Trompeter, S., additional, Tshilolo, L., additional, Wonkam, A., additional, Zilfalil, B. A., additional, Inusa, B., additional, and Kleanthous, M., additional
Published: 2022
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23. Allogeneic hematopoietic stem cell transplantation for adult HLH: a retrospective study by the chronic malignancies and inborn errors working parties of EBMT

Author: Machowicz, R., Suarez, F., Wiktor-Jedrzejczak, W., Eikema, D.J., Wreede, L.C. de, Blok, H.J., Isaksson, C., Einsele, H., Poiré, X., Dorp, S. van, Nikolousis, E., Johansson, J.E., Kobbe, G., Zecca, M., Arnold, R., Gerbitz, A., Finke, J., Díez-Martín, J.L., Bonifazi, F., McQuaker, G., Lenhoff, S., Rohrlich, P.S., Theobald, M., Ljungman, P., Collin, M., Albert, M.H., Ehninger, G., Carlson, K., Halaburda, K., Lehmberg, K., Schönland, S., Yakoub-Agha, I., Gennery, A.R., Lankester, A.C., Kröger, N., Machowicz, R., Suarez, F., Wiktor-Jedrzejczak, W., Eikema, D.J., Wreede, L.C. de, Blok, H.J., Isaksson, C., Einsele, H., Poiré, X., Dorp, S. van, Nikolousis, E., Johansson, J.E., Kobbe, G., Zecca, M., Arnold, R., Gerbitz, A., Finke, J., Díez-Martín, J.L., Bonifazi, F., McQuaker, G., Lenhoff, S., Rohrlich, P.S., Theobald, M., Ljungman, P., Collin, M., Albert, M.H., Ehninger, G., Carlson, K., Halaburda, K., Lehmberg, K., Schönland, S., Yakoub-Agha, I., Gennery, A.R., Lankester, A.C., and Kröger, N.
Abstract: Item does not contain fulltext, Hemophagocytic lymphohistiocytosis (HLH; hemophagocytic syndrome) is a rare syndrome of potentially fatal, uncontrolled hyperinflammation. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is indicated in primary, recurrent or progressive HLH, but information about its outcomes in the adult population is limited. We obtained data about 87 adult (≥18 years of age) patients retrospectively reported to the EBMT. The median survival time was 13.9 months. The three and five-year overall survival (OS) was 44% (95% CI 33-54%). Among 39 patients with a follow-up longer than 15 months, only three died. Relapse rate was 21% (95% CI 13-30%), while NRM reached 36% (95% CI 25-46%). Younger patients (<30 years of age) had better prognosis, with an OS of 59% (95% CI 45-73%) at three and five years vs 23% (95% CI 8-37%) for older ones. No difference in survival between reduced and myeloablative conditioning was found. To our knowledge, this is the largest report of adult HLH patients who underwent allo-HSCT. Patients who survive the first period after this procedure can expect a long disease-free survival. Both reduced intensity and myeloablative conditioning have therapeutic potential in adult HLH.
Published: 2022

24. Myeloablative conditioning with thiotepa-busulfan-fludarabine does not improve the outcome of patients transplanted with active leukemia: final results of the GITMO prospective trial GANDALF-01

Author: Bonifazi, F., Pavoni, C., Peccatori, J., Giglio, F., Arpinati, M., Busca, A., Bernasconi, P., Grassi, A., Iori, A. P., Patriarca, F., Brunello, L., Di Grazia, C., Carella, A. M., Cilloni, D., Picardi, A., Proia, A., Santarone, S., Sorasio, R., Carluccio, P., Chiusolo, Patrizia, Cupri, A., Luppi, M., Nozzoli, C., Baronciani, D., Casini, M., Grillo, G., Musso, M., Onida, F., Palazzo, G., Parma, M., Tringali, S., Vacca, A., Vallisa, D., Sacchi, N., Oldani, E., Masciulli, A., Gheorghiu, A., Girmenia, C., Martino, M., Bruno, B., Rambaldi, A., Ciceri, F., Chiusolo P. (ORCID:0000-0002-1355-1587), Bonifazi, F., Pavoni, C., Peccatori, J., Giglio, F., Arpinati, M., Busca, A., Bernasconi, P., Grassi, A., Iori, A. P., Patriarca, F., Brunello, L., Di Grazia, C., Carella, A. M., Cilloni, D., Picardi, A., Proia, A., Santarone, S., Sorasio, R., Carluccio, P., Chiusolo, Patrizia, Cupri, A., Luppi, M., Nozzoli, C., Baronciani, D., Casini, M., Grillo, G., Musso, M., Onida, F., Palazzo, G., Parma, M., Tringali, S., Vacca, A., Vallisa, D., Sacchi, N., Oldani, E., Masciulli, A., Gheorghiu, A., Girmenia, C., Martino, M., Bruno, B., Rambaldi, A., Ciceri, F., and Chiusolo P. (ORCID:0000-0002-1355-1587)
Abstract: The outcome of refractory/relapsed (R/R) acute leukemias is still dismal and their treatment represents an unmet clinical need. However, allogeneic transplantation (allo-HSCT) remains the only potentially curative approach in this setting. A prospective study (GANDALF-01, NCT01814488; EUDRACT:2012-004008-37) on transplantation with alternative donors had been run by GITMO using a homogeneous myeloablative conditioning regimen with busulfan, thiotepa and fludarabine while GVHD prophylaxis was stratified by donor type. The study enrolled 101 patients; 90 found an alternative donor and 87 ultimately underwent allo-HSCT. Two-year overall survival of the entire and of the transplant population (primary endpoint) were 19% and 22%, without significant differences according to disease, donor type and disease history (relapsed vs refractory patients). Two-year progression-free survival was 19% and 17% respectively. The cumulative incidences of relapse and non-relapse mortality were 49% and 33% at two years. Acute grade II-IV and chronic GVHD occurred in 23 and 10 patients. Dose intensification with a myeloablative two-alkylating regimen as sole strategy for transplanting R/R acute leukemia does seem neither to improve the outcome nor to control disease relapse. A pre-planned relapse prevention should be included in the transplant strategy in this patient population.
Published: 2022

25. GITMO Registry Study on Allogeneic Transplantation in Patients Aged ≥60 Years from 2000 to 2017: Improvements and Criticisms

Author: Malagola, M., Polverelli, N., Rubini, V., Martino, M., Patriarca, F., Bruno, B., Giaccone, L., Grillo, G., Bramanti, S., Bernasconi, P., De Gobbi, M., Natale, A., Terruzzi, E., Olivieri, A., Chiusolo, Patrizia, Carella, A. M., Casini, M., Nozzoli, C., Mazza, P., Bassi, S., Onida, F., Vacca, A., Falcioni, S., Luppi, M., Iori, A. P., Pavone, V., Skert, C., Carluccio, P., Borghero, C., Proia, A., Selleri, C., Sacchi, N., Mammoliti, S., Oldani, E., Ciceri, F., Russo, D., Bonifazi, F., Chiusolo P. (ORCID:0000-0002-1355-1587), Malagola, M., Polverelli, N., Rubini, V., Martino, M., Patriarca, F., Bruno, B., Giaccone, L., Grillo, G., Bramanti, S., Bernasconi, P., De Gobbi, M., Natale, A., Terruzzi, E., Olivieri, A., Chiusolo, Patrizia, Carella, A. M., Casini, M., Nozzoli, C., Mazza, P., Bassi, S., Onida, F., Vacca, A., Falcioni, S., Luppi, M., Iori, A. P., Pavone, V., Skert, C., Carluccio, P., Borghero, C., Proia, A., Selleri, C., Sacchi, N., Mammoliti, S., Oldani, E., Ciceri, F., Russo, D., Bonifazi, F., and Chiusolo P. (ORCID:0000-0002-1355-1587)
Abstract: Today, allogeneic stem cell transplantation (allo-SCT) can be offered to patients up to age 70 to 72 years and represents one of the most effective curative treatments for many hematologic malignancies. The primary objective of the study was to collect data from the allo-SCTs performed in Italy between 2000 and 2017 in patients aged ≥60 years to evaluate the changes in safety and efficacy outcomes, as well as their distribution and characteristics over time. The Italian Group for Bone Marrow Transplantation, Hematopoietic Stem Cells and Cell Therapy (GITMO) AlloEld study (ClinicalTrials.gov identifier NCT04469985) is a retrospective analysis of allo-SCTs performed at 30 Italian transplantation centers in older patients (age ≥60 years) between 2000 and 2017 (n = 1996). For the purpose of this analysis, patients were grouped into 3 time periods: time A, 2000 to 2005 (n = 256; 12%); time B, 2006 to 2011 (n = 584; 29%); and time C, 2012 to 2017 (n = 1156; 59%). After a median follow-up of 5.6 years, the 5-year nonrelapse mortality (NRM) remained stable (time A, 32.8%; time B, 36.2%; and time C, 35.0%; P = .5), overall survival improved (time A, 28.4%; time B, 31.8%; and time C, 37.3%; P = .012), and the cumulative incidence of relapse was reduced (time A, 45.3%; time B, 38.2%; time C, 30.0%; P < .0001). The 2-year incidence of extensive chronic graft-versus-host disease was reduced significantly (time A, 17.2%; time B, 15.8%; time C, 12.2%; P = .004). Considering times A and B together (2000 to 2011), the 2-year NRM was positively correlated with the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score; NRM was 25.2% in patients with an HCT-CI score of 0, 33.9% in those with a score of 1 or 2, and 36.1% in those with a score of 3 (P < .001). However, after 2012, the HCT-CI score was not significantly predictive of NRM. This study shows that the transplantation procedure in elderly patients became more effective over time. Relapse incidence remains t
Published: 2022

26. Successful private–public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines

Author: Ruggieri, L., Giannuzzi, V., Baiardi, P., Bonifazi, F., Davies, E. H., Giaquinto, C., Bonifazi, D., Felisi, M., Chiron, C., Pressler, R., Rabe, H., Whitaker, M. J., Neubert, A., Jacqz-Aigrain, E., Eichler, I., Turner, M. A., Ceci, A., and on behalf of the GRiP Consortium
Published: 2015
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27. Comparative evaluation of biological HLA-DPB1 mismatch models for survival and graft versus host disease prediction after unrelated donor hematopoietic cell transplantation

Author: Lorentino, F, Sacchi, N, Oldani, E, Miotti, V, Picardi, A, Gallina, Am, Crivello, P, Bernasconi, P, Saccardi, R, Farina, L, Benedetti, F, Cerno, M, Grassi, A, Bruno, B, Patriarca, F, Ciceri, F, Fleischhauer, K, Vago, L, Bonifazi, F, Lorentino, F., Sacchi, N., Oldani, E., Miotti, V., Picardi, A., Gallina, A. M., Crivello, P., Bernasconi, P., Saccardi, R., Farina, L., Benedetti, F., Cerno, M., Grassi, A., Bruno, B., Patriarca, F., Ciceri, F., Fleischhauer, K., Vago, L., and Bonifazi, F.
Subjects: HLA, Graft-versus-Host-Disease, unrelated donor selection, Medizin, Settore MED/15, Stem Cell Transplantation
Abstract: CA Fleischhauer
Published: 2020

28. Cytomegalovirus and Epstein-Barr Virus DNA Kinetics in Whole Blood and Plasma of Allogeneic Hematopoietic Stem Cell Transplantation Recipients

Author: Lazzarotto T, Chiereghin A, Piralla A, Piccirilli G, Girello A, Campanini G, Gabrielli L, Costa C, Prete A, Bonifazi F, Busca A, Cairoli R, Colombo AA, Zecca M, Sidoti F, Bianco G, Paba P, Perno CF, Cavallo R, Baldanti F, AMCLI-GLaIT working group., Lazzarotto T, Chiereghin A, Piralla A, Piccirilli G, Girello A, Campanini G, Gabrielli L, Costa C, Prete A, Bonifazi F, Busca A, Cairoli R, Colombo AA, Zecca M, Sidoti F, Bianco G, Paba P, Perno CF, Cavallo R, Baldanti F, AMCLI-GLaIT working group., Tiziana, L, Angela, C, Antonio, P, Giulia, P, Alessia, G, Giulia, C, Liliana, G, Cristina, C, Arcangelo, P, Francesca, B, Alessandro, B, Cairoli, R, Anna Amelia, C, Marco, Z, Francesca, S, Gabriele, B, Pierpaolo, P, Carlo Federico, P, Rossana, C, and Fausto, B
Subjects: Adult, Male, 0301 basic medicine, Herpesvirus 4, Human, medicine.medical_specialty, medicine.medical_treatment, 030106 microbiology, Congenital cytomegalovirus infection, Allogeneic hematopoietic stem cell transplantation, CMV and EBV DNA kinetics, Plasma, Whole blood, Hematology, Transplantation, Cytomegalovirus, Hematopoietic stem cell transplantation, Virus Replication, Virus, 03 medical and health sciences, chemistry.chemical_compound, Internal medicine, medicine, Humans, Aged, Retrospective Studies, CMV and EBV DNA kinetic, business.industry, Hematopoietic Stem Cell Transplantation, virus diseases, Middle Aged, Allografts, medicine.disease, Virology, Transplant Recipients, Kinetics, Blood, 030104 developmental biology, chemistry, Viral replication, DNA, Viral, Female, business, DNA
Abstract: Currently, no consensus has been reached on the optimal blood compartment to be used for surveillance of cytomegalovirus (CMV) and Epstein-Barr virus (EBV) DNAemia. Although several comparative studies have been performed correlating CMV and EBV DNA loads in whole blood (WB) versus plasma, to our knowledge, no studies to date have analyzed the kinetics of both viruses in the 2 blood compartments. In this retrospective noninterventional multicenter cohort study, the kinetics of CMV and EBV DNA in 121 hematopoietic stem cell transplantation (HSCT) recipients were investigated by analyzing in parallel 569 and 351 paired samples from 80 and 58 sequential episodes of CMV and EBV DNAemia, respectively. Unlike previous studies, this study used a single automated molecular method that was CE-marked and Food and Drug Administration-approved for use in quantifying CMV and EBV DNA in both plasma and WB. Furthermore, the complete viral replication kinetics of all episodes (including both the ascending and the descending phases of the active infection) was examined in each patient. The previously observed overall correlation between CMV DNA levels in WB and plasma was confirmed (Spearman's ρ =.85; P
Published: 2018

29. Long‐term outcome of patients receiving haematopoietic allogeneic stem cell transplantation as first transplant for high‐risk Hodgkin lymphoma: a retrospective analysis from the Lymphoma Working Party‐EBMT

Author: Gutiérrez‐García, G., primary, Martínez, C., additional, Boumendil, A., additional, Finel, H., additional, Malladi, R., additional, Afanasyev, B., additional, Tsoulkani, A., additional, Wilson, K. M. O., additional, Bloor, A., additional, Nikoloudis, M., additional, Richardson, D., additional, López‐Corral, L., additional, Castagna, L., additional, Cornelissen, J., additional, Giltat, A., additional, Collin, M., additional, Fanin, R., additional, Bonifazi, F., additional, Robinson, S., additional, Montoto, S., additional, Peggs, K. S., additional, and Sureda, A., additional
Published: 2021
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30. FDG‐PET IMAGING AND RADIOMICS IN RESPONSE ASSESSMENT OF LYMPHOMA PATIENTS UNDERGOING CAR T‐CELL THERAPY

Author: Casadei, B., primary, Paccagnella, A., additional, Farolfi, A., additional, Argnani, L., additional, Malizia, C., additional, Paolani, G., additional, Santoro, M., additional, Della Gala, G., additional, Strolin, S., additional, Strigari, L., additional, Guadagnuolo, S., additional, Bonifazi, F., additional, Fanti, S., additional, and Zinzani, P. L., additional
Published: 2021
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31. The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children

Author: Turner, M.A., Hildebrand, H., Fernandes, R.M., Wildt, S.N. de, Mahler, F., Hankard, R., Leary, R., Bonifazi, F., Nobels, P., Cheng, K., Attar, S., Rossi, P., Rocchi, F., Claverol, J., Nafria, B., Giaquinto, C., Turner, M.A., Hildebrand, H., Fernandes, R.M., Wildt, S.N. de, Mahler, F., Hankard, R., Leary, R., Bonifazi, F., Nobels, P., Cheng, K., Attar, S., Rossi, P., Rocchi, F., Claverol, J., Nafria, B., and Giaquinto, C.
Abstract: Contains fulltext : 232104.pdf (Publisher’s version ) (Open Access), The need for information about new and existing drugs used in children was recognized in the European Union (EU) with the implementation of the Paediatric Regulation in 2007. In 2017, the 10-year review of the Paediatric Regulation identified barriers to the conduct of clinical trials, including delays in setting up and completing paediatric trials. Across Europe, the difficulties with clinical research are compounded by variation within countries and between countries. Ethics and regulatory review have national specificities. This paper describes the Collaborative Network for European Clinical Trials for Children (conect4children, c4c), which addresses selected difficulties in the design and conduct of paediatric clinical trials. c4c is a time-limited public-private consortium funded by the Innovative Medicines Initiative (IMI2). The elements of c4c are as follows: expert advice providing input on study design and/or paediatric development programmes (including patient involvement activities); a network of sites following harmonised procedures coordinated by National Hubs and a single point of contact for Europe; a facility for education and training for sites and trial teams; and support for managing data used by the network and a common paediatric data dictionary. c4c does not sponsor trials. c4c is taking a phased approach with careful piloting through industry and non-industry studies intended to demonstrate the viability of the network (proof-of-viability studies). c4c uses a co-design approach involving industry and academics within a clearly defined scope. A sustainable, successor organization open to all potential service users will be open for business before the end of IMI2 funding in 2024.
Published: 2021

32. Allelic HLA Matching and Pair Origin Are Favorable Prognostic Factors for Unrelated Hematopoietic Stem Cell Transplantation in Neoplastic Hematologic Diseases: An Italian Analysis by the Gruppo Italiano Trapianto di Cellule Staminali e Terapie Cellulari, Italian Bone Marrow Donor Registry, and Associazione Italiana di Immunogenetica e Biologia dei Trapianti

Author: Picardi, A., Sacchi, N., Miotti, V., Lorentino, F., Oldani, E., Rambaldi, A., Sessa, M., Bruno, B., Cerno, M., Vago, L., Bernasconi, P., Arcese, W., Benedetti, F., Pioltelli, P., Russo, D., Farina, L., Fagioli, F., Guidi, S., Saporiti, G., Zallio, F., Chiusolo, Patrizia, Borghero, C., Papalinetti, G., La Rocca, U., Milone, G., Lamparelli, T., Carella, A. M., Luppi, M., Olivieri, A., Martino, M., Carluccio, P., Celeghini, I., Andreani, M., Gallina, A. M., Patriarca, F., Pollichieni, S., Mammoliti, S., Micciche, S., Mangione, I., Ciceri, F., Bonifazi, F., Chiusolo P. (ORCID:0000-0002-1355-1587), Picardi, A., Sacchi, N., Miotti, V., Lorentino, F., Oldani, E., Rambaldi, A., Sessa, M., Bruno, B., Cerno, M., Vago, L., Bernasconi, P., Arcese, W., Benedetti, F., Pioltelli, P., Russo, D., Farina, L., Fagioli, F., Guidi, S., Saporiti, G., Zallio, F., Chiusolo, Patrizia, Borghero, C., Papalinetti, G., La Rocca, U., Milone, G., Lamparelli, T., Carella, A. M., Luppi, M., Olivieri, A., Martino, M., Carluccio, P., Celeghini, I., Andreani, M., Gallina, A. M., Patriarca, F., Pollichieni, S., Mammoliti, S., Micciche, S., Mangione, I., Ciceri, F., Bonifazi, F., and Chiusolo P. (ORCID:0000-0002-1355-1587)
Abstract: HLA molecules are important for immunoreactivity in allogeneic hematopoietic stem cell transplantation (HSCT). The Gruppo Italiano Trapianto di Cellule Staminali e Terapie Cellulari, Italian Bone Marrow Donor Registry, and Associazione Italiana di Immunogenetica e Biologia dei Trapianti promoted a retrospective observational study to evaluate HLA matching and the impact of allelic HLA mismatching and non-HLA factors on unrelated Italian HSCT outcomes. From 2012 to 2015, 1788 patients were enrolled in the study. The average donor age was 29 years and the average recipient age was 49 years. As a conditioning regimen, 71% of the patients received myeloablative conditioning. For GVHD prophylaxis, 76% received either antithymocyte or anti-T lymphocyte globulin, cyclosporine A, and methotrexate. Peripheral blood was the stem cell source in 80%. The median duration of follow-up was 53 months. Regarding HLA matching, 50% of donor-recipient pairs were 10/10 matched, 38% had 1 mismatch, and 12% had 2 or more mismatches. A total of 302 pairs shared Italian origin. Four-year overall survival (OS), progression-free survival, GVHD-free relapse-free survival, and relapse rates were 49%, 40%, 22%, and 34%, respectively. The 4-year NRM was 27%, and the 100-day cumulative incidence of grade ≥II acute GVHD (aGVHD) was 26%. In multivariate analysis, 9/10 and ≤8/10 HLA allele-matched pairs were associated with worse OS (P = .04 and. 007, respectively), NRM (P = .007 and P < .0001, respectively), and grade III-IV aGVHD (P = .0001 and. 01, respectively). Moreover, the incidences of grade II-IV aGVHD (P = .001) and chronic GVHD (P = .002) were significantly lower in Italian pairs. In conclusion, 10/10 HLA matching is a favorable prognostic factor for unrelated HSCT outcome in the Italian population. Moreover, the presence of 2 HLA-mismatched loci was associated with a higher NRM (P < .0001) and grade II-IV aGVHD (P = .006) and a poorer OS (P = .001) compared with 1 HLA-mismatched loc
Published: 2021

33. Intensification of GVHD prophylaxis with low-dose ATG-F before allogeneic PBSC transplantation from HLA-identical siblings in adult patients with hematological malignancies: results from a retrospective analysis

Author: Bonifazi, F, Bandini, G, Arpinati, M, Tolomelli, G, Stanzani, M, Motta, M R, Rizzi, S, Giudice, V, Dan, E, Massari, E, Tazzari, P, Bontadini, A, Pagliaro, P, and Baccarani, M
Published: 2012
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34. Allogeneic transplantation following a reduced-intensity conditioning regimen in relapsed/refractory peripheral T-cell lymphomas: long-term remissions and response to donor lymphocyte infusions support the role of a graft-versus-lymphoma effect

Author: Dodero, A, Spina, F, Narni, F, Patriarca, F, Cavattoni, I, Benedetti, F, Ciceri, F, Baronciani, D, Scimè, R, Pogliani, E, Rambaldi, A, Bonifazi, F, Dalto, S, Bruno, B, and Corradini, P
Published: 2012
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35. HLA matching affects clinical outcome of adult patients undergoing haematopoietic SCT from unrelated donors: a study from the Gruppo Italiano Trapianto di Midollo Osseo and Italian Bone Marrow Donor Registry

Author: Crocchiolo, R, Ciceri, F, Fleischhauer, K, Oneto, R, Bruno, B, Pollichieni, S, Sacchi, N, Sormani, M P, Fanin, R, Bandini, G, Bonifazi, F, Bosi, A, Rambaldi, A, Alessandrino, P E, Falda, M, and Bacigalupo, A
Published: 2009
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36. MULTI-GENOTYPING OF MINOR HISTOCOMPATIBILITY ANTIGENS (MHAGS) IN ALLOGENEIC STEM CELL TRANSPLANTATION AND THEIR ROLE IN DETERMINING GRAFT VERSUS HOST DISEASE (GVHD) AND GRAFT VERSUS LEUKEMIA (GVL) EFFECT: PH-P109

Author: Cattina, F., Skert, C., Bernardi, S., Malagola, M., Ottaviani, E., Bochicchio, M. T., Iacobucci, I., Soverini, S., Bonifazi, F., Bandini, G., Arpinati, M., Motta, M. R., Toffoletti, E., Damiani, D., Santoro, A., Fabbiano, F., Pastore, D., Specchia, G., Console, G., Bruno, M., Carella, G., Malagoli, A., Guadagnuolo, V., De Benedittis, C., Bergonzi, C., Filì, C., Turra, A., Ribolla, R., Cancelli, V., Alghisi, E., Perucca, S., Di Palma, A., Martinelli, G., and Russo, D.
Published: 2014

37. Ocular Graft Versus-host Disease Patients Exhibit Impaired Corneal Biomechanics

Author: Giannaccare, G, Pellegrini, M, Taroni, L, Bernabei, F, Senni, C, Grendele, A, Moscardelli, F, Arpinati, M, Bonifazi, F, Sessa, M, Versura, P, Campos, EC, Giannaccare, G, Pellegrini, M, Taroni, L, Bernabei, F, Senni, C, Grendele, A, Moscardelli, F, Arpinati, M, Bonifazi, F, Sessa, M, Versura, P, and Campos, EC
Subjects: Ocular GVHD, MMP-9, ocular surface, dry eye, inflammation
Abstract: Increased levels of tear matrix metalloproteinase-9 (MMP-9) have been detected in ocular graft versus host disease (oGVHD) patients. Since MMP-9 is a proteolytic enzyme involved in the degradation of corneal extracellular matrix components, we hypothesized that higher tears levels of MMP-9 might impair corneal biomechanics. Therefore, the purpose of this study was to compare corneal biomechanical properties between patients with oGVHD and healthy matched subjects, and to further correlate these values with ocular surface characteristics.
Published: 2019

38. A comparison of data-access platforms for the computing of Large Hadron Collider experiments

Author: Bencivenni, M., Bonifazi, F., Carbone, A., Chierici, A., D'Apice, A., De Girolamo, D., dell'Agnello, L., Donatelli, M., Donvito, G., Fella, A., Furano, F., Galli, D., Ghiselli, A., Italiano, A., Re, G. Lo, Marconi, U., Martelli, B., Mazzucato, M., Onofri, M., Ricci, P.P., Rosso, F., Salomoni, D., Sapunenko, V., Vagnoni, V., Veraldi, R., Vistoli, M.C., Vitlacil, D., and Zani, S.
Subjects: Nuclear research -- Equipment and supplies, Collisions (Nuclear physics) -- Research, Electronic data processing -- Methods, System design -- Methods, Systems analysis -- Methods, Memory (Computers) -- Evaluation, System design, Semiconductor memory, Business, Electronics, Electronics and electrical industries
Abstract: Performance, reliability and scalability in data-access are key issues in the context of the computing Grid and High Energy Physics data processing and analysis applications, in particular considering the large data size and I/O load that a Large Hadron Collider data centre has to support. In this paper we present the technical details and the results of a large scale validation and performance measurement employing different data-access platforms--namely CASTOR, dCache, GPFS and Scalla/Xrootd. The tests have been performed at the CNAF Tier-l, the central computing facility of the Italian National Institute for Nuclear Research (INFN). Our storage back-end was based on Fibre Channel disk-servers organized in a Storage Area Network, being the disk-servers connected to the computing farm via Gigabit LAN. We used 24 disk-servers, 260 TB of raw-disk space and 280 worker nodes as computing clients, able to run concurrently up to about 1100 jobs. The aim of the test was to perform sequential and random read/write accesses to the data, as well as more realistic access patterns, in order to evaluate efficiency, availability, robustness and performance of the various data-access solutions. Index Terms--Computer facilities, computer input-output, data handling, data processing, mass memories, system analysis and design.
Published: 2008

39. Allogeneic stem cell transplantation following reduced-intensity conditioning can induce durable clinical and molecular remissions in relapsed lymphomas: pre-transplant disease status and histotype heavily influence outcome

Author: Corradini, P, Dodero, A, Farina, L, Fanin, R, Patriarca, F, Miceli, R, Matteucci, P, Bregni, M, Scimè, R, Narni, F, Pogliani, E, Locasciulli, A, Milani, R, Carniti, C, Bacigalupo, A, Rambaldi, A, Bonifazi, F, Olivieri, A, Gianni, A M, and Tarella, C
Published: 2007
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40. Treatment of refractory chronic GVHD with rituximab: a GITMO study

Author: Zaja, F, Bacigalupo, A, Patriarca, F, Stanzani, M, Van Lint, M T, Filì, C, Scimè, R, Milone, G, Falda, M, Vener, C, Laszlo, D, Alessandrino, P E, Narni, F, Sica, S, Olivieri, A, Sperotto, A, Bosi, A, Bonifazi, F, and Fanin, R
Published: 2007
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41. Cryotherapy in the prevention of oral mucositis in patients receiving low-dose methotrexate following myeloablative allogeneic stem cell transplantation: a prospective randomized study of the Gruppo Italiano Trapianto di Midollo Osseo nurses group

Author: Gori, E, Arpinati, M, Bonifazi, F, Errico, A, Mega, A, Alberani, F, Sabbi, V, Costazza, G, Leanza, S, Borrelli, C, Berni, M, Feraut, C, Polato, E, Altieri, M C, Pirola, E, Loddo, M C, Banfi, M, Barzetti, L, Calza, S, Brignoli, C, Bandini, G, De Vivo, A, Bosi, A, and Baccarani, M
Published: 2007
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42. Rabbit ATG/ATLG in preventing graft-versus-host disease after allogeneic stem cell transplantation: consensus-based recommendations by an international expert panel

Author: Bonifazi F, Rubio M, Bacigalupo A, Boelens J, Finke J, Greinix H, Mohty M, Nagler A, Passweg J, Rambaldi A, Socie G, Solano C, Walker I, Barosi G, and Kroger N
Subjects: surgical procedures, operative
Abstract: This collaborative initiative aimed to provide recommendations on the use of polyclonal antithymocyte globulin (ATG) or anti-T lymphocyte globulin (ATLG) for the prevention of graft-versus-host disease (GvHD) after allogeneic hematopoietic stem cell transplantation (HSCT). A comprehensive review of articles released up to October, 2018 was performed as a source of scientific evidence. Fourteen clinically relevant key questions to the domains indication, administration, and post-transplant management were developed and recommendations were produced using the Delphi technique involving a Panel of 14 experts. ATG/ATLG was strongly recommended as part of myeloablative conditioning regimen prior to matched or mismatched unrelated bone marrow or peripheral blood allogeneic HSCT in malignant diseases to prevent severe acute and chronic GvHD. ATG/ATLG was also recommended prior to HLA-identical sibling peripheral HSCT with good but lesser bulk of evidence. In reduced intensity or nonmyeloablative conditioning regimens, ATG/ATLG was deemed appropriate to reduce the incidence of acute and chronic GvHD, but a higher risk of relapse should be taken into account. Recommendations regarding dose, application, and premedication were also provided as well as post-transplant infectious prophylaxis and vaccination. Overall, these recommendations can be used for a proper and safe application of polyclonal ATG/ATLG to prevent GvHD after allogeneic HSCT.
Published: 2020

43. Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years

Author: Ceci, A., Felisi, M., Baiardi, P., Bonifazi, F., Catapano, M., Giaquinto, C., Nicolosi, A., Sturkenboom, M., Neubert, A., and Wong, I.
Published: 2006
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44. Benchmarking of survival outcomes following haematopoietic stem cell transplantation: A review of existing processes and the introduction of an international system from the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE).

Author: Snowden, J.A., Saccardi, R., Orchard, K., Ljungman, P., Duarte, R.F., Labopin, M., McGrath, E., Brook, N., Elvira, C.R. de, Gordon, D., Poirel, H.A., Ayuk, F., Beguin, Y., Bonifazi, F., Gratwohl, A., Milpied, N., Moore, J., Passweg, J., Rizzo, J.D., Spellman, S.R., Sierra, J., Solano, C., Sanchez-Guijo, F., Worel, N., Gusi, A., Adams, G., Balan, T., Baldomero, H., Macq, G., Marry, E., Mesnil, F., Oldani, E., Pearce, R., Perry, J., Raus, N., Schanz, U., Tran, S., Wilcox, L., Basak, G.W., Chabannon, C., Corbacioglu, S., Dolstra, H., Kuball, J., Mohty, M., Lankester, A., Montoto, S., Nagler, A., Styczynski, J., Yakoub-Agha, I., Latour, R.P. de, Kroeger, N., Brand, R., Wreede, L.C. de, Zwet, E. van, Putter, H., Snowden, J.A., Saccardi, R., Orchard, K., Ljungman, P., Duarte, R.F., Labopin, M., McGrath, E., Brook, N., Elvira, C.R. de, Gordon, D., Poirel, H.A., Ayuk, F., Beguin, Y., Bonifazi, F., Gratwohl, A., Milpied, N., Moore, J., Passweg, J., Rizzo, J.D., Spellman, S.R., Sierra, J., Solano, C., Sanchez-Guijo, F., Worel, N., Gusi, A., Adams, G., Balan, T., Baldomero, H., Macq, G., Marry, E., Mesnil, F., Oldani, E., Pearce, R., Perry, J., Raus, N., Schanz, U., Tran, S., Wilcox, L., Basak, G.W., Chabannon, C., Corbacioglu, S., Dolstra, H., Kuball, J., Mohty, M., Lankester, A., Montoto, S., Nagler, A., Styczynski, J., Yakoub-Agha, I., Latour, R.P. de, Kroeger, N., Brand, R., Wreede, L.C. de, Zwet, E. van, and Putter, H.
Abstract: 01 april 2020, Contains fulltext : 220877.pdf (Publisher’s version ) (Open Access), In many healthcare settings, benchmarking for complex procedures has become a mandatory requirement by competent authorities, regulators, payers and patients to assure clinical performance, cost-effectiveness and safe care of patients. In several countries inside and outside Europe, benchmarking systems have been established for haematopoietic stem cell transplantation (HSCT), but access is not universal. As benchmarking is now integrated into the FACT-JACIE standards, the EBMT and JACIE established a Clinical Outcomes Group (COG) to develop and introduce a universal system accessible across EBMT members. Established systems from seven European countries (United Kingdom, Italy, Belgium, France, Germany, Spain, Switzerland), USA and Australia were appraised, revealing similarities in process, but wide variations in selection criteria and statistical methods. In tandem, the COG developed the first phase of a bespoke risk-adapted international benchmarking model for one-year survival following allogeneic and autologous HSCT based on current capabilities within the EBMT registry core dataset. Data completeness, which has a critical impact on validity of centre comparisons, is also assessed. Ongoing development will include further scientific validation of the model, incorporation of further variables (when appropriate) alongside implementation of systems for clinically meaningful interpretation and governance aiming to maximise acceptance to centres, clinicians, payers and patients across EBMT.
Published: 2020

45. Transplantation induces profound changes in the transcriptional asset of hematopoietic stem cells: Identification of specific signatures using machine learning techniques

Author: Cilloni, D., Petiti, J., Campia, V., Podesta, M., Squillario, M., Montserrat, N., Bertaina, A., Sabatini, F., Carturan, S., Berger, M., Saglio, F., Bandini, G., Bonifazi, F., Fagioli, F., Moretta, L., Saglio, G., Verri, A., Barla, A., Locatelli, Franco, Frassoni, F., Locatelli F. (ORCID:0000-0002-7976-3654), Cilloni, D., Petiti, J., Campia, V., Podesta, M., Squillario, M., Montserrat, N., Bertaina, A., Sabatini, F., Carturan, S., Berger, M., Saglio, F., Bandini, G., Bonifazi, F., Fagioli, F., Moretta, L., Saglio, G., Verri, A., Barla, A., Locatelli, Franco, Frassoni, F., and Locatelli F. (ORCID:0000-0002-7976-3654)
Abstract: During the phase of proliferation needed for hematopoietic reconstitution following transplantation, hematopoietic stem/progenitor cells (HSPC) must express genes involved in stem cell self-renewal. We investigated the expression of genes relevant for self-renewal and expansion of HSPC (operationally defined as CD34+ cells) in steady state and after transplantation. Specifically, we evaluated the expression of ninety-one genes that were analyzed by real-time PCR in CD34+ cells isolated from (i) 12 samples from umbilical cord blood (UCB); (ii) 15 samples from bone marrow healthy donors; (iii) 13 samples from bone marrow after umbilical cord blood hematopoietic cells. The results show that transplanted CD34+ cells from adult cells acquire an asset very different from transplanted CD34+ cells from cord blood. Multivariate machine learning analysis (MMLA) showed that four specific gene signatures can be obtained by comparing the four types of CD34+ cells. In several, but not all cases, transplanted HSPC from UCB overexpress reprogramming genes. However, these remarkable changes do not alter the commitment to hematopoietic lineage. Overall, these results reveal undisclosed aspects of transplantation biology.
Published: 2020

46. Antiemetic prophylaxis in patients undergoing hematopoietic stem cell transplantation: a multicenter survey of the Gruppo Italiano Trapianto Midollo Osseo (GITMO) transplant programs

Author: Pastore, D., Bruno, B., Carluccio, P., De Candia, M. S., Mammoliti, S., Borghero, C., Chierichini, A., Pavan, F., Casini, M., Pini, M., Nassi, L., Greco, R., Tambaro, F. P., Stefanoni, P., Console, G., Marchesi, F., Facchini, L., Mussetti, A., Cimminiello, M., Saglio, F., Vincenti, D., Falcioni, S., Chiusolo, Patrizia, Olivieri, J., Natale, A., Faraci, M., Cesaro, S., Marotta, S., Proia, A., Donnini, I., Caravelli, D., Zuffa, E., Iori, A. P., Soncini, E., Bozzoli, V., Pisapia, G., Scalone, R., Villani, O., Prete, A., Ferrari, A., Menconi, M., Mancini, G., Gigli, F., Gargiulo, G., Patriarca, F., Bonifazi, F., Chiusolo P. (ORCID:0000-0002-1355-1587), Pastore, D., Bruno, B., Carluccio, P., De Candia, M. S., Mammoliti, S., Borghero, C., Chierichini, A., Pavan, F., Casini, M., Pini, M., Nassi, L., Greco, R., Tambaro, F. P., Stefanoni, P., Console, G., Marchesi, F., Facchini, L., Mussetti, A., Cimminiello, M., Saglio, F., Vincenti, D., Falcioni, S., Chiusolo, Patrizia, Olivieri, J., Natale, A., Faraci, M., Cesaro, S., Marotta, S., Proia, A., Donnini, I., Caravelli, D., Zuffa, E., Iori, A. P., Soncini, E., Bozzoli, V., Pisapia, G., Scalone, R., Villani, O., Prete, A., Ferrari, A., Menconi, M., Mancini, G., Gigli, F., Gargiulo, G., Patriarca, F., Bonifazi, F., and Chiusolo P. (ORCID:0000-0002-1355-1587)
Abstract: A survey within hematopoietic stem cell transplant (HSCT) centers of the Gruppo Italiano Trapianto Midollo Osseo (GITMO) was performed in order to describe current antiemetic prophylaxis in patients undergoing HSCT. The multicenter survey was performed by a questionnaire, covering the main areas on chemotherapy-induced nausea and vomiting (CINV): antiemetic prophylaxis guidelines used, antiemetic prophylaxis in different conditioning regimens, and methods of CINV evaluation. The survey was carried out in November 2016, and it was repeated 6 months after the publication of the Multinational Association of Supportive Care in Cancer (MASCC)/European Society for Medical Oncology (ESMO) specific guidelines on antiemetic prophylaxis in HSCT. The results show a remarkable heterogeneity of prophylaxis among the various centers and a significant difference between the guidelines and the clinical practice. In the main conditioning regimens, the combination of a serotonin3 receptor antagonist (5-HT3-RA) with dexamethasone and neurokin1 receptor antagonist (NK1-RA), as recommended by MASCC/ESMO guidelines, increased from 0 to 15% (before the publication of the guidelines) to 9–30% (after the publication of the guidelines). This study shows a lack of compliance with specific antiemetic guidelines, resulting mainly in under-prophylaxis. Concerted strategies are required to improve the current CINV prophylaxis, to draft shared common guidelines, and to increase the knowledge and the adherence to the current recommendations for CINV prophylaxis in the specific field of HSCT.
Published: 2020

47. Short- and long-term haematological surveillance of healthy donors of allogeneic peripheral haematopoietic progenitors mobilized with G-CSF: a single institution prospective study

Author: Tassi, C, Tazzari, P L, Bonifazi, F, Giudice, V, Nannetti, A, Ricci, F, Rizzi, S, Bandini, G, and Conte, R
Published: 2005
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48. Reduced incidence of GVHD without increase in relapse with low-dose rabbit ATG in the preparative regimen for unrelated bone marrow transplants in CML

Author: Bonifazi, F, Bandini, G, Rondelli, D, Falcioni, S, Stanzani, M, Bontadini, A, Tazzari, P L, Arpinati, M, Giannini, B, Conte, R, and Baccarani, M
Published: 2003
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49. A phase II study of α-interferon and oral arabinosyl cytosine (YNK01) in chronic myeloid leukemia

Author: Rosti, G, Bonifazi, F, Trabacchi, E, de Vivo, A, Bassi, S, Martinelli, G, Testoni, N, Russo, D, and Baccarani, M
Published: 2003
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50. The CIBMTR score predicts survival of AML patients undergoing allogeneic transplantation with active disease after a myeloablative or reduced intensity conditioning: a retrospective analysis of the Gruppo Italiano Trapianto Di Midollo Osseo

Author: Todisco, E, Ciceri, F, Oldani, E, Boschini, C, Micò, C, VanLint, M T, Donnini, I, Patriarca, F, Alessandrino, P E, Bonifazi, F, Arcese, W, Barberi, W, Marenco, P, Terruzzi, E, Cortelazzo, S, Santarone, S, Proia, A, Corradini, P, Tagliaferri, E, Falcioni, S, Irrera, G, Dallanegra, L, Castagna, L, Santoro, A, Camboni, A, Sacchi, N, Bosi, A, Bacigalupo, A, and Rambaldi, A
Published: 2013
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