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1. Artificial intelligence methods to estimate overall mortality and non-relapse mortality following allogeneic HCT in the modern era: an EBMT-TCWP study

Author

Mussetti, A., Rius-Sansalvador, B., Moreno, V., Peczynski, C., Polge, E., Galimard, J. E., Kröger, N., Blaise, D., Peffault de Latour, R., Kulagin, A., Mousavi, A., Stelljes, M., Hamladji, R. M., Middeke, J. M., Salmenniemi, U., Sengeloev, H., Forcade, E., Platzbecker, U., Reményi, P., Angelucci, E., Chevallier, P., Yakoub-Agha, I., Craddock, C., Ciceri, F., Schroeder, T., Aljurf, M., Ch, Koenecke, Moiseev, I., Penack, O., Schoemans, H., Mohty, M., Glass, B., Sureda, A., Basak, G., and Peric, Z.

Published
2024
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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

Purpose: Allogeneic hematopoietic cell transplantation (HCT) improves outcomes for patients with acute myeloid leukemia (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. Methods: Adults 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. Results: Three 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). Conclusion: Although 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. Artificial intelligence methods to estimate overall mortality and non-relapse mortality following allogeneic HCT in the modern era: an EBMT-TCWP study

Author

Mussetti, A., primary, Rius-Sansalvador, B., additional, Moreno, V., additional, Peczynski, C., additional, Polge, E., additional, Galimard, J. E., additional, Kröger, N., additional, Blaise, D., additional, Peffault de Latour, R., additional, Kulagin, A., additional, Mousavi, A., additional, Stelljes, M., additional, Hamladji, R. M., additional, Middeke, J. M., additional, Salmenniemi, U., additional, Sengeloev, H., additional, Forcade, E., additional, Platzbecker, U., additional, Reményi, P., additional, Angelucci, E., additional, Chevallier, P., additional, Yakoub-Agha, I., additional, Craddock, C., additional, Ciceri, F., additional, Schroeder, T., additional, Aljurf, M., additional, Ch, Koenecke, additional, Moiseev, I., additional, Penack, O., additional, Schoemans, H., additional, Mohty, M., additional, Glass, B., additional, Sureda, A., additional, Basak, G., additional, and Peric, Z., additional

Published
2023
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4. OUTCOMES IN PATIENTS WITH B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA RECEIVING INOTUZUMAB OZOGAMICIN AND PROCEEDING TO HEMATOPOIETIC STEM CELL TRANSPLANTATION

Author

De-Lima, M, primary, Kebriaei, P, additional, Lanza, F, additional, Cho, C, additional, Popradi, G, additional, Kaur, M, additional, Zhang, M, additional, Zhang, F, additional, Vandendries, E, additional, Asomaning, K, additional, Dorman, S, additional, Stelljes, M, additional, Marks, DI, additional, Cury, A, additional, and Saber, W, additional

Published
2023
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6. Axicabtagene ciloleucel (Axicel) for relapsed/refractory primary mediastinal B‐cell lymphoma (r/r PMBCL) compared to DLBCL‐NOS: A GLA/DRST registry study.

Author

Schubert, M., primary, Ayuk, F. A., additional, Bethge, W., additional, von Bonin, M., additional, Vucinic, V., additional, Wagner‐Drouet, E. M., additional, Subklewe, M., additional, Baldus, C. D., additional, Glass, B., additional, Marks, R., additional, Mougiakakos, D., additional, Schroers, R., additional, Stelljes, M., additional, Topp, M. S., additional, Wulf, G., additional, Kröger, N., additional, and Dreger, P., additional

Published
2023
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7. Anti-CD3/CD7 immunoconjugate (T-Guard) for severe, steroid-refractory GVHD: final report of BMT CTN 2002.

Author

Meyers, G., Hamadani, M., Martens, M., Ali, H., Chevallier, P., Choe, H., Harris, A.C., Holler, E., Hooren, E. van, Klaassen, W., Leifer, E., Oosterhout, Y. van, Perez, L., Pusic, I., Stelljes, M., Velden, W.J.F.M. van der, Ammatuna, E., Beauvais, D., Cornillon, J., Maziarz, R.T., Schetelig, J., Romeril, J., MacMillan, M.L., Levine, J.E., Socié, G., Meyers, G., Hamadani, M., Martens, M., Ali, H., Chevallier, P., Choe, H., Harris, A.C., Holler, E., Hooren, E. van, Klaassen, W., Leifer, E., Oosterhout, Y. van, Perez, L., Pusic, I., Stelljes, M., Velden, W.J.F.M. van der, Ammatuna, E., Beauvais, D., Cornillon, J., Maziarz, R.T., Schetelig, J., Romeril, J., MacMillan, M.L., Levine, J.E., and Socié, G.

Abstract

Contains fulltext : 299881.pdf (Publisher’s version ) (Closed access), 01 december 2023

Published
2023

8. Defibrotide plus best standard of care compared with best standard of care alone for the prevention of sinusoidal obstruction syndrome (HARMONY): a randomised, multicentre, phase 3 trial

Author

Grupp, S. A., Corbacioglu, S., Kang, H. J., Teshima, T., Khaw, S. L., Locatelli, Franco, Maertens, J., Stelljes, M., Stepensky, P., Lopez, P., Amber, V., Pagliuca, A., Richardson, P. G., Mohty, M., Locatelli F. (ORCID:0000-0002-7976-3654), Grupp, S. A., Corbacioglu, S., Kang, H. J., Teshima, T., Khaw, S. L., Locatelli, Franco, Maertens, J., Stelljes, M., Stepensky, P., Lopez, P., Amber, V., Pagliuca, A., Richardson, P. G., Mohty, M., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

Background: Sinusoidal obstruction syndrome, also known as veno-occlusive disease, is a potentially life-threatening complication of haematopoietic stem-cell transplantation (HSCT). We aimed to compare defibrotide prophylaxis plus best supportive care versus best supportive care alone for sinusoidal obstruction syndrome prevention after HSCT. Methods: This open-label, randomised, multicentre, phase 3 trial was done in 104 centres in 14 countries. Patients who were at least 1 month old, were scheduled to receive allogeneic HSCT (adult [aged >16 years] or paediatric [aged >1 month to ≤16 years] patients) or autologous HSCT (paediatric patients only), and were at high risk or very high risk of developing sinusoidal obstruction syndrome were eligible for inclusion. Patients were randomly assigned (1:1) by an interactive web response system to receive intravenous defibrotide 25 mg/kg per day (four equal doses [6·25 mg/kg per dose]) and best supportive care (determined by individual institutional guidelines; defibrotide prophylaxis group) or best supportive care only (best supportive care group). Randomisation was stratified by sinusoidal obstruction syndrome risk, age, and country. The primary endpoint, sinusoidal obstruction syndrome-free survival at day 30 after HSCT, was assessed by an independent Endpoint Adjudication Committee in the intention-to-treat (ITT) population. Safety was assessed in all patients who received protocol treatment. The trial is registered with ClinicalTrials.gov, NCT02851407. Findings: Between Jan 11, 2017, and Oct 20, 2020, 372 patients (172 [46%] women and 200 [54%] men; median age 14·0 years [IQR 4·0–41·0] were randomly assigned to the defibrotide prophylaxis group (n=190) or best supportive care group (n=182; ITT population). On the basis of recommendations from the Independent Data Monitoring Committee following completion of the planned interim analysis in the first 280 recruited patients on April 29, 2020, enrolment was prematurel

Published
2023

11. Total body irradiation/fludarabine versus busulfan/fludarabine as conditioning in all patients > 45 years in 1sr CR - a registry-based study by the ALWP of the EBMT [Abstract]

Author

Hirschbühl, Klaus, Labopin, M., Polge, E., Schmid, Christoph, Blaise, D., Bourhis, J. H., Socie, G., Forcade, E., Yakoub-Agha, I., Labussiere-Wallet, H., Bethge, W., Chevallier, P., Fegueux, N., Stelljes, M., Spyridonidis, A., Peric, Z., Brissot, E., Savani, B., Giebel, S., Nagler, A., and Mohty, M.

Subjects
ddc:610
Published
2022

16. Age, not therapy intensity, determines outcomes of adults with acute myeloid leukemia

Author

Büchner, T, Krug, U O, Peter Gale, R, Heinecke, A, Sauerland, M C, Haferlach, C, Schnittger, S, Haferlach, T, Müller-Tidow, C, Stelljes, M, Mesters, R M, Serve, H L, Braess, J, Spiekermann, K, Staib, P, Grüneisen, A, Reichle, A, Balleisen, L, Eimermacher, H, Giagounidis, A, Rasche, H, Lengfelder, E, Görlich, D, Faldum, A, Köpcke, W, Hehlmann, R, Wörmann, B J, Berdel, W E, and Hiddemann, W

Published
2016
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17. Increasing intensity of therapies assigned at diagnosis does not improve survival of adults with acute myeloid leukemia

Author

Krug, U, Berdel, W E, Gale, R P, Haferlach, C, Schnittger, S, Müller-Tidow, C, Braess, J, Spiekermann, K, Staib, P, Beelen, D, Serve, H, Schliemann, C, Stelljes, M, Balleisen, L, Maschmeyer, G, Grüneisen, A, Eimermacher, H, Giagounidis, A, Rasche, H, Hehlmann, R, Lengfelder, E, Thiel, E, Reichle, A, Aul, C, Ludwig, W-D, Kern, W, Haferlach, T, Köpcke, W, Görlich, D, Sauerland, M C, Heinecke, A, Wörmann, B J, Hiddemann, W, and Büchner, T

Published
2016
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19. Azacitidine in combination with intensive induction chemotherapy in older patients with acute myeloid leukemia: The AML-AZA trial of the study alliance leukemia

Author

Müller-Tidow, C, Tschanter, P, Röllig, C, Thiede, C, Koschmieder, A, Stelljes, M, Koschmieder, S, Dugas, M, Gerss, J, Butterfaß-Bahloul, T, Wagner, R, Eveslage, M, Thiem, U, Krause, S W, Kaiser, U, Kunzmann, V, Steffen, B, Noppeney, R, Herr, W, Baldus, C D, Schmitz, N, Götze, K, Reichle, A, Kaufmann, M, Neubauer, A, Schäfer-Eckart, K, Hänel, M, Peceny, R, Frickhofen, N, Kiehl, M, Giagounidis, A, Görner, M, Repp, R, Link, H, Kiani, A, Naumann, R, Brümmendorf, T H, Serve, H, Ehninger, G, Berdel, W E, and Krug, U

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. Allogeneic stem cell transplantation after conditioning with treosulfan, etoposide and cyclophosphamide for patients with ALL: a phase II-study on behalf of the German Cooperative Transplant Study Group and ALL Study Group (GMALL)

Author

Kröger, N, Bornhäuser, M, Stelljes, M, Pichlmeier, U, Trenschel, R, Schmid, C, Arnold, R, Martin, H, Heinzelmann, M, Wolschke, C, Meyer, R G, Bethge, W, Kobbe, G, Ayuk, F, Gökbuget, N, Hölzer, D, Zander, A, and Beelen, D

Published
2015
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22. P1448: LONG-TERM SURVIVORS AFTER FAILURE OF CAR-T CELL THERAPY FOR R/R LARGE B-CELL LYMPHOMA (LBCL): A GLA/DRST STUDY

Author

Derigs, P., primary, Bethge, W., additional, Holtick, U., additional, von Tresckow, B., additional, Ayuk, F., additional, Penack, O., additional, Vucinic, V., additional, von Bonin, M., additional, Baldus, C., additional, Mougiakakos, D., additional, Wulf, G., additional, Schnetzke, U., additional, Stelljes, M., additional, Thomas, S., additional, Schroers, R., additional, Kroeger, N., additional, and Dreger, P., additional

Published
2022
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23. Hematopoietic cell transplantation in patients with intermediate and high-risk AML: results from the randomized Study Alliance Leukemia (SAL) AML 2003 trial

Author

Schetelig, J, Schaich, M, Schäfer-Eckart, K, Hänel, M, Aulitzky, W E, Einsele, H, Schmitz, N, Rösler, W, Stelljes, M, Baldus, C D, Ho, A D, Neubauer, A, Serve, H, Mayer, J, Berdel, W E, Mohr, B, Oelschlägel, U, Parmentier, S, Röllig, C, Kramer, M, Platzbecker, U, Illmer, T, Thiede, C, Bornhäuser, M, and Ehninger, G

Published
2015
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26. Faktoren assoziiert mit Langzeitüberleben nach Versagen einer chimären Antigen-Rezeptor (CAR) T-Zell-Therapie für rezidivierte oder refraktäre großzellige B-Zell-Lymphome : eine Rolle für die allogene Stammzelltransplantation?

Author

Derigs, P., Bethge, W., Holtick, U., von Tresckow, Bastian, Ayuk, F., Penack, O., Vucinic, V., von Bonin, M., Baldus, C., Mougiakakos, D., Wulf, G., Schnetzke, U., Stelljes, M., Thomas, S., Schroers, R., Kroeger, N., and Dreger, P.

Subjects
Medizin
Published
2022

29. Prognostic factors for cellular therapies ‐ CART and allogeneic SCT ‐ in relapsed /refractory large B cell lymphoma (LBCL).

Author

Glass, B., Sureda, A., Boumendil, A., Dreger, P., Corradini, P., Ram, R., Kroeger, N., Castagna, L., Pabst, T., Kwon, M., Wulf, G., García‐Sancho, A. M., Solano, C., Stelljes, M., Reinhardt, H. C., Rubio, M. T., Malladi, R., Blaise, D., Besley, C., and Forcade, E.

Subjects
B cell lymphoma, CD19 antigen, PROGNOSIS, CELLULAR therapy
Abstract

In multivariate analysis patients with IPI (o-2) low risk at cell therapy show better OS (HR 0.81, 95% CI 0.59-1.1, I p i < 0.0001) and PFS (HR 0.62, CI: 0.46-0.83, I p i = 0.00145), comparable RI and lower NRM (HR 0.21 CI: 0.11-0.42, I p i = 0.00001) with CART compared to allo SCT. B Introduction: b Allogeneic stem cell transplantation (alloSCT) was the only curative option for younger patients (pts) with relapsed/ refractory (r/ r) LBCL (DLBCL, tFL, PMBCL). Prognostic factors for cellular therapies - CART and allogeneic SCT - in relapsed /refractory large B cell lymphoma (LBCL). [Extracted from the article]

Published
2023
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30. Efficacy and toxicity of CAR T‐cell therapy in patients with primary and secondary central nervous system lymphoma—an analysis of the EBMT Lymphoma WP and the GoCART coalition.

Author

Laube, A., Fuhrmann, S., Peczynski, C., Boumendil, A., Michel, E., Finel, H., Galimard, J., Beauvais, D., Daskalakis, M., Novak, U., Kröger, N., Stelljes, M., von Tresckow, B., Wulf, G. G., Dreger, P., Sureda, A., Schmitz, N., and Glaß, B.

Subjects
CENTRAL nervous system, DIFFUSE large B-cell lymphomas, LYMPHOMAS, T cells
Abstract

B Conclusion: b With a 51% OS-rate at 12 months CART seem to be a very effective therapeutic option in heavily pre-treated r/r PCNSL or SCNSL, particularly for pts being refractory to prior therapy. Pts with involvement of the CNS were excluded from most CART trials; however, anecdotal reports suggest that CART might be an effective treatment option for such pts. B Introduction: b The prognosis of patients (pts) with diffuse large B-cell lymphoma (DLBCL) and involvement of the central nervous system (CNS) remains dismal. [Extracted from the article]

Published
2023
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32. Randomized comparison of prophylactic and minimal residual disease-triggered imatinib after allogeneic stem cell transplantation for BCR–ABL1-positive acute lymphoblastic leukemia

Author

Pfeifer, H, Wassmann, B, Bethge, W, Dengler, J, Bornhäuser, M, Stadler, M, Beelen, D, Vucinic, V, Burmeister, T, Stelljes, M, Faul, C, Dreger, P, Kiani, A, Schäfer-Eckart, K, Schwerdtfeger, R, Lange, E, Kubuschok, B, Horst, H A, Gramatzki, M, Brück, P, Serve, H, Hoelzer, D, Gökbuget, N, and Ottmann, O G

Published
2013
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33. OUTCOME DETERMINANTS OF COMMERCIAL CAR‐T CELL THERAPY FOR LARGE B‐CELL LYMPHOMA: RESULTS OF THE GLA/DRST REAL WORLD ANALYSIS

Author

Dreger, P., primary, Martus, P., additional, Holtick, U., additional, Ayuk, F., additional, Wagner‐Drouet, E. M., additional, Wulf, G., additional, Marks, R., additional, Penack, O., additional, Koenecke, C., additional, von Bonin, M., additional, von Tresckow, B., additional, Stelljes, M., additional, Baldus, C., additional, Vucinic, V., additional, Mougiakakos, D., additional, Topp, M., additional, Wolff, D., additional, Schroers, R., additional, Schmitt, M., additional, Schmitt, T., additional, Lengerke, C., additional, Thomas, S., additional, Beelen, D. W., additional, and Bethge, W., additional

Published
2021
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34. Total body irradiation plus fludarabine compared to busulfan plus fludarabine as 'reduced-toxicity conditioning' for patients with acute myeloid leukemia treated with allogeneic hematopoietic cell transplantation in first complete remission: a study by the Acute Leukemia Working Party of the EBMT

Author

Giebel, S, Labopin, M, Sobczyk-Kruszelnicka, M, Stelljes, M, Byrne, JL, Fegueux, N, Beelen, DW, Rovira, M, Spyridonidis, A, Blaise, D, Bornhauser, M, Karadogan, I, Savani, BN, Nagler, A, Mohty, M, Martin, S, Chevallier, P, Neubauer, A, Damaj, G, Koc, Y, Ganser, A, Collin, M, Yakoub-Agha, I, Ozdogu, H, Araujo, MC, Itala-Remes, M, Orchard, K, Isaksson, C, Bethge, W, Martin, H, Aljurf, M, Faber, E, Caballero, D, Zak, P, Leleu, X, Bay, JO, Rohrlich, PS, Kroger, N, Huynh, A, Schafer-Eckart, K, Milpied, N, Lenhoff, S, Ho, A, Lopez, JLB, Mordini, N, Lioure, B, Halaburda, K, Olivieri, A, Gedde-Dahl, T, Protheroe, R, Tischer, J, Klammer, M, Clausen, J, Potter, V, Ladetto, M, Tilly, H, Deconinck, E, Brecht, A, Muller, LP, Heinicke, T, Carrete, JPT, Bazarbachi, A, Remenyi, P, Rubio, MT, Fanin, R, Perez-Simon, JA, Niels, M, Diez-Martin, JL, Arat, M, Hermine, O, Socie, G, Cornelissen, JJ, Santarone, S, Guyotat, D, Bulabois, CE, Bernasconi, P, Johansson, JE, Vrhovac, R, Greinix, H, Lorenzo, JLL, Apte, S, Craddock, C, Kobbe, G, Zahrani, MA, Dreger, P, Lange, A, Tbakhi, A, Meijer, E, Llamas, CV, Santasusana, JMR, Corradini, P, Benedetti, F, Rambaldi, A, Gandemer, V, Malfuson, JV, Kaare, A, Risitano, A, Petrini, M, Selleri, C, and Wu, DP

Abstract

The optimal conditioning for patients with acute myeloid leukemia in first complete remission treated with allogeneic hematopoietic cell transplantation (allo-HCT) has not been defined so far. In this retrospective study, we compared two "reduced-toxicity" regimens: intravenous busulfan at a total dose of 9.6 mg/kg (3 days) + fludarabine (Bu3/Flu) and total body irradiation at a dose of 8 Gy + fludarabine (TBI8Gy/Flu). In the entire study cohort (n = 518), the probabilities of overall survival (OS), leukemia-free survival (LFS), relapse and non-relapse mortality (NRM) at 2 years for Bu3/Flu and TBI8Gy/Flu were 62% vs. 72.5% (p = 0.051), 59.5% vs. 65% (p = 0.15), 30% vs. 20% (p = 0.01), and 10% vs. 14% (p = 0.18), respectively. In multivariate model for patients

Published
2021

38. 18F-FDG-PET-MRT der akuten intestinalen GvHD

Author

Roll, W, additional, Schindler, P, additional, Masthoff, M, additional, Strotmann, R, additional, Noto, B, additional, Reicherts, C, additional, Albring, J, additional, Weckesser, M, additional, Stelljes, M, additional, Schäfers, M, additional, and Evers, G, additional

Published
2021
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39. External validation of models for KIR2DS1/KIR3DL1-informed selection of hematopoietic cell donors fails

Author

Schetelig, J., Baldauf, H., Heidenreich, F., Massalski, C., Frank, S., Sauter, J., Stelljes, M., Ayuk, F.A., Bethge, W.A., Bug, G., Klein, S., Wendler, S., Lange, V., Wreede, L.C. de, Furst, D., Kobbe, G., Ottinger, H.D., Beelen, D.W., Mytilineos, J., Fleischhauer, K., Schmidt, A.H., Bomhauser, M., German Cooperative Transp, and Deutsch Register Stammzelltransp

Subjects
Adult, Male, Oncology, medicine.medical_specialty, Genotype, Immunobiology and Immunotherapy, medicine.medical_treatment, Immunology, Medizin, Graft vs Host Disease, Human leukocyte antigen, Hematopoietic stem cell transplantation, Biochemistry, Donor Selection, Young Adult, Receptors, KIR, Internal medicine, medicine, Humans, Transplantation, Homologous, Cumulative incidence, Aged, Proportional Hazards Models, Retrospective Studies, Donor selection, Proportional hazards model, business.industry, Hazard ratio, Hematopoietic Stem Cell Transplantation, Receptors, KIR3DL1, Cell Biology, Hematology, Middle Aged, Transplantation, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Female, Unrelated Donors, business, KIR3DL1
Abstract

Several studies suggest that harnessing natural killer (NK) cell reactivity mediated through killer cell immunoglobulin-like receptors (KIRs) could reduce the risk of relapse after allogeneic hematopoietic cell transplantation. Based on one promising model, information on KIR2DS1 and KIR3DL1 and their cognate ligands can be used to classify donors as KIR-advantageous or KIR-disadvantageous. This study was aimed at externally validating this model in unrelated donor hematopoietic cell transplantation. The impact of the predictor on overall survival (OS) and relapse incidence was tested in a Cox regression model adjusted for patient age, a modified disease risk index, Karnofsky performance status, donor age, HLA match, sex match, cytomegalovirus match, conditioning intensity, type of T-cell depletion, and graft type. Data from 2222 patients with acute myeloid leukemia or myelodysplastic syndrome were analyzed. KIR genes were typed by using high-resolution amplicon-based next-generation sequencing. In univariable analyses and subgroup analyses, OS and the cumulative incidence of relapse of patients with a KIR-advantageous donor were comparable to patients with a KIR-disadvantageous donor. The adjusted hazard ratio from the multivariable Cox regression model was 0.99 (Wald test, P = .93) for OS and 1.04 (Wald test, P = .78) for relapse incidence. We also tested the impact of activating donor KIR2DS1 and inhibition by KIR3DL1 separately but found no significant impact on OS and the risk of relapse. Thus, our study shows that the proposed model does not universally predict NK-mediated disease control. Deeper knowledge of NK-mediated alloreactivity is necessary to predict its contribution to graft-versus-leukemia reactions and to eventually use KIR genotype information for donor selection.

Published
2020

49. A randomized study comparing two schedules of Imatinib Intervention after allogeneic stem cell transplantation (SCT) for Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL): V103

Author

Pfeifer, H., Wassmann, B., Bethge, W., Dengler, J., Bornhäuser, M., Stadler, M., Beelen, D., Günther, A., Vucinic, V., Burmeister, T., Stelljes, M., Schwerdtfeger, R., Schäfer-Eckhart, K., Bader, P., Kreyenberg, H., Schuld, P., Serve, H., Hoelzer, D., Goekbuget, N., and Ottmann, O. G.

Published
2011

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