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21 results on '"Griskevicius L"'

1. An early post-transplant relapse prediction score in multiple myeloma: a large cohort study from the chronic malignancies working party of EBMT

Author

Beksac, M., Iacobelli, S., Koster, Linda (Extern), Cornelissen, J, Griskevicius, L., Rabin, N.K., Stoppa, A.M., Meijer, E., Mear, J.B., Zeerleder, S., Mayer, J., Fenk, R., Fegueux, N., Chevallier, P., Konirova, E., Snowden, J.A., Engelhardt, M., Orchard, K., Hulin, C., Schaap, N.P., Sossa, C., Elmaagacli, A., McLornan, D.P., Hayden, P.J., Schönland, S., Yakoub-Agha, I., Beksac, M., Iacobelli, S., Koster, Linda (Extern), Cornelissen, J, Griskevicius, L., Rabin, N.K., Stoppa, A.M., Meijer, E., Mear, J.B., Zeerleder, S., Mayer, J., Fenk, R., Fegueux, N., Chevallier, P., Konirova, E., Snowden, J.A., Engelhardt, M., Orchard, K., Hulin, C., Schaap, N.P., Sossa, C., Elmaagacli, A., McLornan, D.P., Hayden, P.J., Schönland, S., and Yakoub-Agha, I.

Abstract

Item does not contain fulltext, Early relapse (ER) following Autologous Hematopoietic Cell Transplantation (AHCT) confers a poor prognosis. We therefore developed a novel scoring system to predict ER. A total of 14,367 AHCT-1 patients were transplanted between 2014 and 2019, and were conditioned with Melphalan 200 mg/m(2) (Mel200) (n = 7228; 2014-2017) (training cohort); Mel200 (n = 5616; 2018-2019) or Mel140 (n = 1523; 2018-2019) (validation cohorts). PFS-12 and the Cumulative Incidence of Relapse at 12 months were 84.1% and 14.7% (training Mel200), 87.2% and 11.6% (validation Mel200), and 80.3% and 16.9% (validation Mel140), respectively. The points in the risk score were: 0, 1,2 for ISS stages I, II, and III; Disease status: 0 (CR/VGPR); 1 (PR); 2 (SD/MR); 4 (Relapse/Progression); and 1 for Karnofsky ≤ 70. The distribution of scores: 0 (24%), 1 (33.9%), 2 (29.6 %), 3 (9.5%), and ≥4 (2.7%). The score separated PFS-12, with the lowest risk group (n = 1752) having a PFS-12 of 91.7% and the highest risk group (n = 195) 57.1%. This also applied in cytogenetically high-risk patients. If the pre-score baseline risks are 15% (standard risk) and 25% (high-risk), a score of ≥4 confers calculated risks of 38% and 54%, respectively. This novel EBMT ER score, therefore, allows for the identification of five discrete prognostic groups.

Published
2023

2. T-cell acute lymphoblastic leukemia in patients 1-45 years treated with the pediatric NOPHO ALL2008 protocol

Author

Quist-Paulsen, P., Toft, N., Heyman, M., Abrahamsson, J., Griskevicius, L., Hallbook, H., Jonsson, O. G., Palk, K., Vaitkeviciene, G., Vettenranta, K., Asberg, A., Frandsen, T. L., Opdahl, S., Marquart, H. V., Siitonen, S., Osnes, L. T., Hultdin, Magnus, Overgaard, U. M., Wartiovaara-Kautto, U., Schmiegelow, K., Quist-Paulsen, P., Toft, N., Heyman, M., Abrahamsson, J., Griskevicius, L., Hallbook, H., Jonsson, O. G., Palk, K., Vaitkeviciene, G., Vettenranta, K., Asberg, A., Frandsen, T. L., Opdahl, S., Marquart, H. V., Siitonen, S., Osnes, L. T., Hultdin, Magnus, Overgaard, U. M., Wartiovaara-Kautto, U., and Schmiegelow, K.

Abstract

The NOPHO ALL2008 is a population-based study using an unmodified pediatric protocol in patients 1-45 years of age with acute lymphoblastic leukemia. Patients with T-ALL were given a traditional pediatric scheme if fast responding (minimal residual disease (MRD) < 0.1% day 29), or intensive block-based chemotherapy if slow responding (MRD > 0.1% day 29). Both treatment arms included pediatric doses of high-dose methotrexate and asparaginase. If MRD >= 5% on day 29 or >= 0.1% after consolidation, patients were assigned to allogeneic hematopoietic stem cell transplantation. The 5-year overall survival of the 278 T-ALL patients was 0.75 (95% CI 0.69-0.81), being 0.82 (0.74-0.88) for patients 1.0-9.9 years, 0.76 (0.66-0.86) for those 10.0-17.9 years, and 0.65 (0.55-0.75) for the older patients. The risk of death in first remission was significantly higher in adults (12%) compared with the 1-9 years group (4%). The MRD responses in the three age groups were similar, and only a nonsignificant increase in relapse risk was found in adults. In conclusion, an unmodified pediatric protocol in patients 1-45 years is effective in all age groups. The traditional pediatric treatment schedule was safe for all patients, but the intensive block therapy led to a high toxic death rate in adults.

Published
2020
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3. Ibrutinib added to 10-day decitabine for older patients with AML and higher risk MDS

Author

Huls, G. (Gerwin), Chitu, D.A., Pabst, T. (Thomas), Klein, SK, Stussi, G. (Georg), Griskevicius, L., Valk, P.J.M. (Peter), Cloos, J. (Jacqueline), de Loosdrecht, AAV, Breems, D.A. (Dimitri), van Lammeren - Venema, D. (Danielle), van Zeventer, I., Boersma, R., Jongen-Lavrencic, M. (Mojca), Fehr, M., Hoogendoorn, M. (Martine), Manz, MG, Söhne, M. (Maaike), Kooy, RV, Deeren, D., van der Poel, M.W.M., Legdeur, MC, Tick, L.W. (Lidwine), Chalandon, Y. (Yves), Ammatuna, E., Blum, S., Löwenberg, B. (Bob), Ossenkoppele, G.J. (Gert), Huls, G. (Gerwin), Chitu, D.A., Pabst, T. (Thomas), Klein, SK, Stussi, G. (Georg), Griskevicius, L., Valk, P.J.M. (Peter), Cloos, J. (Jacqueline), de Loosdrecht, AAV, Breems, D.A. (Dimitri), van Lammeren - Venema, D. (Danielle), van Zeventer, I., Boersma, R., Jongen-Lavrencic, M. (Mojca), Fehr, M., Hoogendoorn, M. (Martine), Manz, MG, Söhne, M. (Maaike), Kooy, RV, Deeren, D., van der Poel, M.W.M., Legdeur, MC, Tick, L.W. (Lidwine), Chalandon, Y. (Yves), Ammatuna, E., Blum, S., Löwenberg, B. (Bob), and Ossenkoppele, G.J. (Gert)

Abstract

The treatment of older, unfit patients with acute myeloid leukemia (AML) is challenging. Based on preclinical data of Bruton tyrosine kinase expression/phosphorylation and ibrutinib cytotoxicity in AML blasts, we conducted a randomized phase 2 multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in unfit (ie, Hematopoietic Cell Transplantation Comorbidity Index ≥3) AML patients and higher risk myelodysplasia patients (HOVON135/SAKK30/15 trial). In total, 144 eligible patients were randomly (1:1) assigned to either 10-day decitabine combined with ibrutinib (560 mg; sequentially given, starting the day after the last dose of decitabine) (n = 72) or to 10-day decitabine (n = 72). The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms. In the decitabine plus ibrutinib arm, 41% reached complete remission/complete remission with incomplete hematologic recovery (CR/CRi), the median overall survival (OS) was 11 months, and 2-year OS was 27%; these findings compared with 50% CR/CRi, median OS of 11.5 months, and 2-year OS of 21% for the decitabine group (not significant). Extensive molecular profiling at diagnosis revealed that patients with STAG2, IDH2, and ASXL1 mutations had significantly lower CR/CRi rates, whereas patients with mutations in TP53 had significantly higher CR/CRi rates. Furthermore, multicolor flow cytometry revealed that after 3 cycles of treatment, 28 (49%) of 57 patients with available bone marrow samples had no measurable residual disease. In this limited number of cases, measurable residual disease revealed no apparent impact on event-free survival and OS. In conclusion, the addition of ibrutinib does not improve the therapeutic efficacy of decitabine. This trial was registered at the Netherlands Trial Register (NL5751 [NTR6017]) and has EudraCT number 2015-002855-85.

Published
2020
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4. T-cell acute lymphoblastic leukemia in patients 1-45 years treated with the pediatric NOPHO ALL2008 protocol

Author

Quist-Paulsen, P., Toft, N., Heyman, M., Abrahamsson, J., Griskevicius, L., Hallböök, Helene, Jonsson, O. G., Palk, K., Vaitkeviciene, G., Vettenranta, K., Asberg, A., Frandsen, T. L., Opdahl, S., Marquart, H. V., Siitonen, S., Osnes, L. T., Hultdin, M., Overgaard, U. M., Wartiovaara-Kautto, U., Schmiegelow, K., Quist-Paulsen, P., Toft, N., Heyman, M., Abrahamsson, J., Griskevicius, L., Hallböök, Helene, Jonsson, O. G., Palk, K., Vaitkeviciene, G., Vettenranta, K., Asberg, A., Frandsen, T. L., Opdahl, S., Marquart, H. V., Siitonen, S., Osnes, L. T., Hultdin, M., Overgaard, U. M., Wartiovaara-Kautto, U., and Schmiegelow, K.

Abstract

The NOPHO ALL2008 is a population-based study using an unmodified pediatric protocol in patients 1-45 years of age with acute lymphoblastic leukemia. Patients with T-ALL were given a traditional pediatric scheme if fast responding (minimal residual disease (MRD) < 0.1% day 29), or intensive block-based chemotherapy if slow responding (MRD > 0.1% day 29). Both treatment arms included pediatric doses of high-dose methotrexate and asparaginase. If MRD >= 5% on day 29 or >= 0.1% after consolidation, patients were assigned to allogeneic hematopoietic stem cell transplantation. The 5-year overall survival of the 278 T-ALL patients was 0.75 (95% CI 0.69-0.81), being 0.82 (0.74-0.88) for patients 1.0-9.9 years, 0.76 (0.66-0.86) for those 10.0-17.9 years, and 0.65 (0.55-0.75) for the older patients. The risk of death in first remission was significantly higher in adults (12%) compared with the 1-9 years group (4%). The MRD responses in the three age groups were similar, and only a nonsignificant increase in relapse risk was found in adults. In conclusion, an unmodified pediatric protocol in patients 1-45 years is effective in all age groups. The traditional pediatric treatment schedule was safe for all patients, but the intensive block therapy led to a high toxic death rate in adults.

Published
2020
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5. Ibrutinib added to 10-day decitabine for older patients with AML and higher risk MDS

Author

Huls, G, Chitu, Dana, Pabst, T, Klein, SK, Stussi, G, Griskevicius, L, Valk, Peter, Cloos, J, de Loosdrecht, AAV, Breems, D, van Lammeren-Venema, D, van Zeventer, I, Boersma, R, Jongen - Lavrencic, Mojca, Fehr, M, Hoogendoorn - Lips, EJI, Manz, MG, Sohne, M, Kooy, RV, Deeren, D, van der Poel, MWM, Legdeur, MC, Tick, L, Chalandon, Y, Ammatuna, E, Blum, S, Löwenberg, Bob, Ossenkoppele, GJ, Huls, G, Chitu, Dana, Pabst, T, Klein, SK, Stussi, G, Griskevicius, L, Valk, Peter, Cloos, J, de Loosdrecht, AAV, Breems, D, van Lammeren-Venema, D, van Zeventer, I, Boersma, R, Jongen - Lavrencic, Mojca, Fehr, M, Hoogendoorn - Lips, EJI, Manz, MG, Sohne, M, Kooy, RV, Deeren, D, van der Poel, MWM, Legdeur, MC, Tick, L, Chalandon, Y, Ammatuna, E, Blum, S, Löwenberg, Bob, and Ossenkoppele, GJ

Published
2020

6. Post-transplant cyclophosphamide versus antithymocyte globulin in patients with acute myeloid leukemia in first complete remission undergoing allogeneic stem cell transplantation from 10/10 HLA-matched unrelated donors

Author

Brissot, E, Labopin, M, Moiseev, I, Cornelissen, Jan, Meijer, E, van Gorkom, G, Rovira, M, Ciceri, F, Griskevicius, L, Blaise, D, Forcade, E, Mistrik, M, Mielke, S, Bulabois, CE, Niittyvuopio, R, Deconinck, E, Ruggeri, A, Sanz, J, Spyridonidis, A, Savani, B, Giebel, S, Nagler, A, Mohty, M, Brissot, E, Labopin, M, Moiseev, I, Cornelissen, Jan, Meijer, E, van Gorkom, G, Rovira, M, Ciceri, F, Griskevicius, L, Blaise, D, Forcade, E, Mistrik, M, Mielke, S, Bulabois, CE, Niittyvuopio, R, Deconinck, E, Ruggeri, A, Sanz, J, Spyridonidis, A, Savani, B, Giebel, S, Nagler, A, and Mohty, M

Published
2020

7. Long-term survival of patients with CLL after allogeneic transplantation: A report from the European Society for Blood and Marrow Transplantation

Author

Van Gelder, M, De Wreede, L, Bornhauser, M, Niederwieser, D, Karas, M, Anderson, N, Gramatzki, M, Dreger, P, Michallet, M, Petersen, E, Bunjes, D, Potter, M, Beelen, D, Cornelissen, J, Yakoub-Agha, I, Russell, N, Finke, J, Schoemans, H, Vitek, A, Urbano-Ispizua, A, Blaise, D, Volin, L, Chevallier, P, Caballero, D, Putter, H, Van Biezen, A, Henseler, A, Schonland, S, Kroger, N, Schetelig, J, Ehninger, G, Jindra, P, Sengeloev, H, Ispizua, A, Arnold, R, Veelken, J, Mufti, G, Milpied, N, Benedetto, B, Schaap, M, Leblond, V, Nikolousis, M, Hallek, M, Passweg, J, Ljungman, P, Masszi, T, Stelljes, M, Browne, P, Glass, B, Espiga, C, Bourhis, J, Roussy, G, Gribben, J, Foa, R, Sierra, J, Mayer, J, Thomson, K, Meijer, E, Blau, W, Holler, E, Bacigalupo, A, Guilhot, F, Carlson, K, Zachee, P, Ifrah, N, Marin, J, Socie, G, Mcquaker, G, Cortelezzi, A, Lenhoff, S, Tischer, J, Irrera, G, Fanin, R, Beguin, Y, Nagler, A, Mackinnon, S, Itala-Remes, M, Deconinck, E, Wulf, G, Corradini, P, Gilleece, M, Wing, B, Peniket, A, Ganser, A, Stuhler, G, Faber, E, Komarnicki, M, Kanz, L, Brune, M, Lamy, T, Sanz, M, Kyrcz-Krzemien, S, Orchard, K, Hunter, A, Sandstedt, A, Fegueux, N, Bandini, G, Robinson, S, Craddock, C, Crawley, C, Griskevicius, L, Bloor, A, Reman, O, Hilgendorf, I, Cannell, P, Ciceri, F, Kalhs, P, Sica, S, Greinix, H, Scime, R, Selleslag, D, Kruger, W, Huynh, A, Einsele, H, Bittenbring, J, Olivieri, A, Hermine, O, Gedde-Dahl, T, Zsiros, J, Guyotat, D, Cordonnier, C, Campos, A, Casini, M, Martinelli, G, Muller, L, Van Imhoff, G, Neubauer, A, Lioure, B, Hamladji, R, Noens, L, Theobald, M, Salvi, F, Ram, R, Poire, X, Or, R, Chalandon, Y, Solano, C, Wilson, K, Santasusana, J, Karakasis, D, Schafer-Eckart, K, Wahlin, A, Mohty, M, Velardi, A, Bron, D, Alegre, A, Cairoli, R, Marotta, G, Lange, A, Narni, F, Fauser, A, Rambaldi, A, Guillerm, G, Heras, I, Snowden, J, Wiktor-Jedrzejczak, W, Schanz, U, Cahn, J, Abecasis, M, Kobbe, G, Salim, R, Junghanss, C, Segel, E, Clement, L, Zak, P, Metzner, B, Espigado, I, Tilly, H, Schroyens, W, Favre, C, Russo, D, Gastl, G, Bay, J, Alessandrino, E, Majolino, I, Bosi, A, Zuckerman, T, Aljurf, M, Thomson, J, Pioltelli, P, Anagnostopoulos, A, Schouten, H, Tholouli, E, Gurman, G, Vural, F, Zver, S, Muniz, S, Afanasyev, B, Pohlreich, D, Hellmann, A, Rosler, W, Martin, S, Apperley, J, Finnegan, D, Renaud, M, Nemet, D, Culligan, D, Castagna, L, Cascavilla, N, Koh, M, Chacon, M, Ozdogu, H, Spencer, A, Llamas, C, Grasso, M, Lopez, S, Benedetti, F, Deeren, D, De Revel, T, Musso, M, Halaburda, K, Sureda, A, Angelucci, E, Diez-Martin, J, Hunter, H, Koc, Y, Bordessoule, D, Fouillard, L, Di Bartolomeo, P, Mazza, P, Novitzky, N, Peschel, C, Lopez, J, Cascon, M, Romeril, K, Schots, R, Brussel, H, Koistinen, P, Arcese, W, Aktan, M, Rodeghiero, F, Butler, A, Pizzuti, M, Melpignano, A, Carella, A, Valcarcel, D, De Toledo Codina, J, Galieni, P, Bader, P, Hahn, Cavanna, L, Sucak, G, Broom, A, Garcia, P, Nicolas-Virelizier, E, Rizzoli, V, Witz, F, Collin, M, Ringhoffer, M, Kansu, E, Martin, H, Moraleda, J, Pranger, D, Greil, R, Bazarbachi, A, Ozturk, M, Fagioli, F, Jantunen, E, Yeshurun, M, Altuntas, F, Bassan, R, Rohrlich, P, Jimenez, S, Glaisner, S, Vinante, O, Clausen, J, Lopez-Jimenez, J, Theunissen, K, Specchia, G, Pavone, V, Krauter, J, Edwards, D, Rifon, J, Everaus, H, Da Prada, G, Wattad, M, Milone, G, Walewski, J, Thieblemont, C, Nasa, G, Duchosal, M, Ferrara, F, Devidas, A, Delmer, A, Degos, L, Van Gelder M., De Wreede L. C., Bornhauser M., Niederwieser D., Karas M., Anderson N. S., Gramatzki M., Dreger P., Michallet M., Petersen E., Bunjes D., Potter M., Beelen D., Cornelissen J. J., Yakoub-Agha I., Russell N. H., Finke J., Schoemans H., Vitek A., Urbano-Ispizua A., Blaise D., Volin L., Chevallier P., Caballero D., Putter H., Van Biezen A., Henseler A., Schonland S., Kroger N., Schetelig J., Ehninger G., Jindra P., Sengeloev H., Russell N., Ispizua A. U., Arnold R., Veelken J. H., Mufti G., Milpied N., Benedetto B., Schaap M., Leblond V., Nikolousis M., Hallek M., Passweg J., Ljungman P., Masszi T., Stelljes M., Browne P., Glass B., Espiga C. R., Bourhis J. H., Roussy G., Gribben J., Foa R., Sierra J., Mayer J., Thomson K., Meijer E., Blau W., Holler E., Bacigalupo A., Guilhot F., Carlson K., Zachee P., Ifrah N., Marin J. R. C., Socie G., McQuaker G., Cortelezzi A., Lenhoff S., Tischer J., Irrera G., Fanin R., Beguin Y., Nagler A., Mackinnon S., Itala-Remes M., Deconinck E., Wulf G., Corradini P., Gilleece M., Wing B., Peniket A., Ganser A., Stuhler G., Faber E., Komarnicki M., Kanz L., Brune M., Lamy T., Sanz M., Kyrcz-Krzemien S., Orchard K., Hunter A., Sandstedt A., Fegueux N., Bandini G., Robinson S., Craddock C., Crawley C., Griskevicius L., Bloor A., Reman O., Hilgendorf I., Cannell P., Ciceri F., Kalhs P., Sica S., Greinix H., Scime R., Selleslag D., Kruger W., Huynh A., Einsele H., Bittenbring J., Olivieri A., Hermine O., Gedde-Dahl T., Zsiros J., Guyotat D., Cordonnier C., Campos A., Casini M., Martinelli G., Muller L. P., Van Imhoff G., Neubauer A., Lioure B., Hamladji R. -M., Noens L., Theobald M., Salvi F., Ram R., Poire X., Or R., Chalandon Y., Solano C., Wilson K., Santasusana J. M. R., Karakasis D., Schafer-Eckart K., Wahlin A., Mohty M., Velardi A., Bron D., Alegre A., Cairoli R., Marotta G., Lange A., Narni F., Fauser A., Rambaldi A., Guillerm G., Heras I., Snowden J., Wiktor-Jedrzejczak W., Schanz U., Cahn J. Y., Abecasis M., Kobbe G., Salim R., Junghanss C., Segel E. K., Clement L., Zak P., Metzner B., Espigado I., Tilly H., Schroyens W., Favre C., Russo D., Gastl G., Bay J. -O., Alessandrino E. P., Majolino I., Bosi A., Zuckerman T., Aljurf M., Thomson J., Pioltelli P., Anagnostopoulos A., Schouten H., Tholouli E., Gurman G., Vural F., Zver S., Muniz S. G., Afanasyev B., Pohlreich D., Hellmann A., Rosler W., Martin S., Apperley J., Finnegan D., Renaud M., Nemet D., Culligan D., Castagna L., Cascavilla N., Koh M., Chacon M. J., Ozdogu H., Spencer A., Llamas C. V., Grasso M., Lopez S. G., Benedetti F., Deeren D., De Revel T., Musso M., Halaburda K., Sureda A., Angelucci E., Diez-Martin J. L., Hunter H., Koc Y., Bordessoule D., Fouillard L., Di Bartolomeo P., Mazza P., Novitzky N., Peschel C., Lopez J. L. B., Cascon M. J. P., Romeril K. R., Schots R., Brussel H., Koistinen P., Arcese W., Aktan M., Rodeghiero F., Butler A., Pizzuti M., Melpignano A., Carella A. M., Valcarcel D., De Toledo Codina J. S., Galieni P., Bader P., Cavanna L., Sucak G., Broom A. J. M., Garcia P. G., Nicolas-Virelizier E., Rizzoli V., Witz F., Collin M., Ringhoffer M., Kansu E., Martin H., Moraleda J., Pranger D., Greil R., Bazarbachi A., Ozturk M., Fagioli F., Jantunen E., Yeshurun M., Altuntas F., Bassan R., Rohrlich P. -S., Jimenez S., Glaisner S., Vinante O., Clausen J., Lopez-Jimenez J., Theunissen K., Specchia G., Pavone V., Krauter J., Edwards D., Rifon J., Everaus H., Da Prada G. A., Wattad M., Milone G., Walewski J., Thieblemont C., Nasa G. L., Duchosal M., Ferrara F., Devidas A., Delmer A., Degos L., Van Gelder, M, De Wreede, L, Bornhauser, M, Niederwieser, D, Karas, M, Anderson, N, Gramatzki, M, Dreger, P, Michallet, M, Petersen, E, Bunjes, D, Potter, M, Beelen, D, Cornelissen, J, Yakoub-Agha, I, Russell, N, Finke, J, Schoemans, H, Vitek, A, Urbano-Ispizua, A, Blaise, D, Volin, L, Chevallier, P, Caballero, D, Putter, H, Van Biezen, A, Henseler, A, Schonland, S, Kroger, N, Schetelig, J, Ehninger, G, Jindra, P, Sengeloev, H, Ispizua, A, Arnold, R, Veelken, J, Mufti, G, Milpied, N, Benedetto, B, Schaap, M, Leblond, V, Nikolousis, M, Hallek, M, Passweg, J, Ljungman, P, Masszi, T, Stelljes, M, Browne, P, Glass, B, Espiga, C, Bourhis, J, Roussy, G, Gribben, J, Foa, R, Sierra, J, Mayer, J, Thomson, K, Meijer, E, Blau, W, Holler, E, Bacigalupo, A, Guilhot, F, Carlson, K, Zachee, P, Ifrah, N, Marin, J, Socie, G, Mcquaker, G, Cortelezzi, A, Lenhoff, S, Tischer, J, Irrera, G, Fanin, R, Beguin, Y, Nagler, A, Mackinnon, S, Itala-Remes, M, Deconinck, E, Wulf, G, Corradini, P, Gilleece, M, Wing, B, Peniket, A, Ganser, A, Stuhler, G, Faber, E, Komarnicki, M, Kanz, L, Brune, M, Lamy, T, Sanz, M, Kyrcz-Krzemien, S, Orchard, K, Hunter, A, Sandstedt, A, Fegueux, N, Bandini, G, Robinson, S, Craddock, C, Crawley, C, Griskevicius, L, Bloor, A, Reman, O, Hilgendorf, I, Cannell, P, Ciceri, F, Kalhs, P, Sica, S, Greinix, H, Scime, R, Selleslag, D, Kruger, W, Huynh, A, Einsele, H, Bittenbring, J, Olivieri, A, Hermine, O, Gedde-Dahl, T, Zsiros, J, Guyotat, D, Cordonnier, C, Campos, A, Casini, M, Martinelli, G, Muller, L, Van Imhoff, G, Neubauer, A, Lioure, B, Hamladji, R, Noens, L, Theobald, M, Salvi, F, Ram, R, Poire, X, Or, R, Chalandon, Y, Solano, C, Wilson, K, Santasusana, J, Karakasis, D, Schafer-Eckart, K, Wahlin, A, Mohty, M, Velardi, A, Bron, D, Alegre, A, Cairoli, R, Marotta, G, Lange, A, Narni, F, Fauser, A, Rambaldi, A, Guillerm, G, Heras, I, Snowden, J, Wiktor-Jedrzejczak, W, Schanz, U, Cahn, J, Abecasis, M, Kobbe, G, Salim, R, Junghanss, C, Segel, E, Clement, L, Zak, P, Metzner, B, Espigado, I, Tilly, H, Schroyens, W, Favre, C, Russo, D, Gastl, G, Bay, J, Alessandrino, E, Majolino, I, Bosi, A, Zuckerman, T, Aljurf, M, Thomson, J, Pioltelli, P, Anagnostopoulos, A, Schouten, H, Tholouli, E, Gurman, G, Vural, F, Zver, S, Muniz, S, Afanasyev, B, Pohlreich, D, Hellmann, A, Rosler, W, Martin, S, Apperley, J, Finnegan, D, Renaud, M, Nemet, D, Culligan, D, Castagna, L, Cascavilla, N, Koh, M, Chacon, M, Ozdogu, H, Spencer, A, Llamas, C, Grasso, M, Lopez, S, Benedetti, F, Deeren, D, De Revel, T, Musso, M, Halaburda, K, Sureda, A, Angelucci, E, Diez-Martin, J, Hunter, H, Koc, Y, Bordessoule, D, Fouillard, L, Di Bartolomeo, P, Mazza, P, Novitzky, N, Peschel, C, Lopez, J, Cascon, M, Romeril, K, Schots, R, Brussel, H, Koistinen, P, Arcese, W, Aktan, M, Rodeghiero, F, Butler, A, Pizzuti, M, Melpignano, A, Carella, A, Valcarcel, D, De Toledo Codina, J, Galieni, P, Bader, P, Hahn, Cavanna, L, Sucak, G, Broom, A, Garcia, P, Nicolas-Virelizier, E, Rizzoli, V, Witz, F, Collin, M, Ringhoffer, M, Kansu, E, Martin, H, Moraleda, J, Pranger, D, Greil, R, Bazarbachi, A, Ozturk, M, Fagioli, F, Jantunen, E, Yeshurun, M, Altuntas, F, Bassan, R, Rohrlich, P, Jimenez, S, Glaisner, S, Vinante, O, Clausen, J, Lopez-Jimenez, J, Theunissen, K, Specchia, G, Pavone, V, Krauter, J, Edwards, D, Rifon, J, Everaus, H, Da Prada, G, Wattad, M, Milone, G, Walewski, J, Thieblemont, C, Nasa, G, Duchosal, M, Ferrara, F, Devidas, A, Delmer, A, Degos, L, Van Gelder M., De Wreede L. C., Bornhauser M., Niederwieser D., Karas M., Anderson N. S., Gramatzki M., Dreger P., Michallet M., Petersen E., Bunjes D., Potter M., Beelen D., Cornelissen J. J., Yakoub-Agha I., Russell N. H., Finke J., Schoemans H., Vitek A., Urbano-Ispizua A., Blaise D., Volin L., Chevallier P., Caballero D., Putter H., Van Biezen A., Henseler A., Schonland S., Kroger N., Schetelig J., Ehninger G., Jindra P., Sengeloev H., Russell N., Ispizua A. U., Arnold R., Veelken J. H., Mufti G., Milpied N., Benedetto B., Schaap M., Leblond V., Nikolousis M., Hallek M., Passweg J., Ljungman P., Masszi T., Stelljes M., Browne P., Glass B., Espiga C. R., Bourhis J. H., Roussy G., Gribben J., Foa R., Sierra J., Mayer J., Thomson K., Meijer E., Blau W., Holler E., Bacigalupo A., Guilhot F., Carlson K., Zachee P., Ifrah N., Marin J. R. C., Socie G., McQuaker G., Cortelezzi A., Lenhoff S., Tischer J., Irrera G., Fanin R., Beguin Y., Nagler A., Mackinnon S., Itala-Remes M., Deconinck E., Wulf G., Corradini P., Gilleece M., Wing B., Peniket A., Ganser A., Stuhler G., Faber E., Komarnicki M., Kanz L., Brune M., Lamy T., Sanz M., Kyrcz-Krzemien S., Orchard K., Hunter A., Sandstedt A., Fegueux N., Bandini G., Robinson S., Craddock C., Crawley C., Griskevicius L., Bloor A., Reman O., Hilgendorf I., Cannell P., Ciceri F., Kalhs P., Sica S., Greinix H., Scime R., Selleslag D., Kruger W., Huynh A., Einsele H., Bittenbring J., Olivieri A., Hermine O., Gedde-Dahl T., Zsiros J., Guyotat D., Cordonnier C., Campos A., Casini M., Martinelli G., Muller L. P., Van Imhoff G., Neubauer A., Lioure B., Hamladji R. -M., Noens L., Theobald M., Salvi F., Ram R., Poire X., Or R., Chalandon Y., Solano C., Wilson K., Santasusana J. M. R., Karakasis D., Schafer-Eckart K., Wahlin A., Mohty M., Velardi A., Bron D., Alegre A., Cairoli R., Marotta G., Lange A., Narni F., Fauser A., Rambaldi A., Guillerm G., Heras I., Snowden J., Wiktor-Jedrzejczak W., Schanz U., Cahn J. Y., Abecasis M., Kobbe G., Salim R., Junghanss C., Segel E. K., Clement L., Zak P., Metzner B., Espigado I., Tilly H., Schroyens W., Favre C., Russo D., Gastl G., Bay J. -O., Alessandrino E. P., Majolino I., Bosi A., Zuckerman T., Aljurf M., Thomson J., Pioltelli P., Anagnostopoulos A., Schouten H., Tholouli E., Gurman G., Vural F., Zver S., Muniz S. G., Afanasyev B., Pohlreich D., Hellmann A., Rosler W., Martin S., Apperley J., Finnegan D., Renaud M., Nemet D., Culligan D., Castagna L., Cascavilla N., Koh M., Chacon M. J., Ozdogu H., Spencer A., Llamas C. V., Grasso M., Lopez S. G., Benedetti F., Deeren D., De Revel T., Musso M., Halaburda K., Sureda A., Angelucci E., Diez-Martin J. L., Hunter H., Koc Y., Bordessoule D., Fouillard L., Di Bartolomeo P., Mazza P., Novitzky N., Peschel C., Lopez J. L. B., Cascon M. J. P., Romeril K. R., Schots R., Brussel H., Koistinen P., Arcese W., Aktan M., Rodeghiero F., Butler A., Pizzuti M., Melpignano A., Carella A. M., Valcarcel D., De Toledo Codina J. S., Galieni P., Bader P., Cavanna L., Sucak G., Broom A. J. M., Garcia P. G., Nicolas-Virelizier E., Rizzoli V., Witz F., Collin M., Ringhoffer M., Kansu E., Martin H., Moraleda J., Pranger D., Greil R., Bazarbachi A., Ozturk M., Fagioli F., Jantunen E., Yeshurun M., Altuntas F., Bassan R., Rohrlich P. -S., Jimenez S., Glaisner S., Vinante O., Clausen J., Lopez-Jimenez J., Theunissen K., Specchia G., Pavone V., Krauter J., Edwards D., Rifon J., Everaus H., Da Prada G. A., Wattad M., Milone G., Walewski J., Thieblemont C., Nasa G. L., Duchosal M., Ferrara F., Devidas A., Delmer A., and Degos L.

Abstract

Even with the availability of targeted drugs, allogeneic hematopoietic cell transplantation (allo-HCT) is the only therapy with curative potential for patients with CLL. Cure can be assessed by comparing long-term survival of patients to the matched general population. Using data from 2589 patients who received allo-HCT between 2000 and 2010, we used landmark analyses and methods from relative survival analysis to calculate excess mortality compared with an age-, sex- and calendar year-matched general population. Estimated event-free survival, overall survival and non-relapse mortality (NRM) 10 years after allo-HCT were 28% (95% confidence interval (CI), 25-31), 35% (95% CI, 32-38) and 40% (95% CI, 37-42), respectively. Patients who passed the 5-year landmark event-free survival (N=394) had a 79% probability (95% CI, 73-85) of surviving the subsequent 5 years without an event. Relapse and NRM contributed equally to treatment failure. Five-year mortality for 45- and 65-year-old reference patients who were event-free at the 5-year landmark was 8% and 47% compared with 3% and 14% in the matched general population, respectively. The prospect of long-term disease-free survival remains an argument to consider allo-HCT for young patients with high-risk CLL, and programs to understand and prevent late causes of failure for long-term survivors are warranted, especially for older patients.

Published
2017

8. Results of NOPHO ALL2008 treatment for patients aged 1-45 years with acute lymphoblastic leukemia

Author

Toft, N., Birgens, H., Abrahamsson, J., Griskevicius, L., Hallböök, H., Heyman, M., Klausen, T. W., Jónsson, O. G., Palk, K., Pruunsild, K., Quist-Paulsen, P., Vaitkeviciene, G., Vettenranta, K., Åsberg, A., Frandsen, T. L., Marquart, H. V., Madsen, H. O., Norén-Nyström, Ulrika, Schmiegelow, K., Toft, N., Birgens, H., Abrahamsson, J., Griskevicius, L., Hallböök, H., Heyman, M., Klausen, T. W., Jónsson, O. G., Palk, K., Pruunsild, K., Quist-Paulsen, P., Vaitkeviciene, G., Vettenranta, K., Åsberg, A., Frandsen, T. L., Marquart, H. V., Madsen, H. O., Norén-Nyström, Ulrika, and Schmiegelow, K.

Abstract

Adults with acute lymphoblastic leukemia (ALL) do worse than children. From 7/2008 to 12/2014, Nordic and Baltic centers treated 1509 consecutive patients aged 1-45 years with Philadelphia chromosome-negative ALL according to the NOPHO ALL2008 without cranial irradiation. Overall, 1022 patients were of age 1-9 years (A), 266 were 10-17 years (B) and 221 were 18-45 years (C). Sixteen patients (three adults) died during induction. All others achieved remission after induction or 1-3 intensive blocks. Subsequently, 45 patients (12 adults) died, 122 patients relapsed (32 adults) with a median time to relapse of 1.6 years and 13 (no adult) developed a second malignancy. Median follow-up time was 4.6 years. Among the three age groups, older patients more often had higher risk ALL due to T-ALL (32%/25%/9%, P<0.001), KMT2A rearrangements (6%/5%/3%, P<0.001) and higher day 29 residual leukemia for B-lineage (P<0.001), but not T-ALL (P = 0.53). Event-free survival rates (pEFS(5y)) were 89 +/- 1% (A), 80 +/- 3% (B) and 74 +/- 4% (C) with significant differences only for non-high risk groups. Except for thrombosis, pancreatitis and osteonecrosis, the risk of 19 specified toxicities was not enhanced by age above 10 years. In conclusion, a pediatric-based protocol is tolerable and effective for young adults, despite their increased frequency of higher risk features.

Published
2018
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9. Treatment and outcome of 2904 CML patients from the EUTOS population-based registry

Author

Hoffmann, V S, Baccarani, M, Hasford, J, Castagnetti, F, Di Raimondo, F, Casado, L F, Turkina, A, Zackova, D, Ossenkoppele, G, Zaritskey, A, Höglund, Martin, Simonsson, Bengt, Indrak, K, Sninska, Z, Sacha, T, Clark, R, Bogdanovic, A, Hellmann, A, Griskevicius, L, Schubert-Fritschle, G, Sertic, D, Guilhot, J, Lejniece, S, Zupan, I, Burgstaller, S, Koskenvesa, P, Everaus, H, Costeas, P, Lindoerfer, D, Rosti, G, Saussele, S, Hochhaus, A, Hehlmann, R, Hoffmann, V S, Baccarani, M, Hasford, J, Castagnetti, F, Di Raimondo, F, Casado, L F, Turkina, A, Zackova, D, Ossenkoppele, G, Zaritskey, A, Höglund, Martin, Simonsson, Bengt, Indrak, K, Sninska, Z, Sacha, T, Clark, R, Bogdanovic, A, Hellmann, A, Griskevicius, L, Schubert-Fritschle, G, Sertic, D, Guilhot, J, Lejniece, S, Zupan, I, Burgstaller, S, Koskenvesa, P, Everaus, H, Costeas, P, Lindoerfer, D, Rosti, G, Saussele, S, Hochhaus, A, and Hehlmann, R

Abstract

The European Treatment and Outcome Study (EUTOS) population-based registry includes data of all adult patients newly diagnosed with Philadelphia chromosome-positive and/or BCR-ABL1+ chronic myeloid leukemia (CML) in 20 predefined countries and regions of Europe. Registration time ranged from 12 to 60 months between January 2008 and December 2013. Median age was 55 years and median observation time was 29 months. Eighty percent of patients were treated first line with imatinib, and 17% with a second-generation tyrosine kinase inhibitor, mostly according to European LeukemiaNet recommendations. After 12 months, complete cytogenetic remission (CCyR) and major molecular response (MMR) were achieved in 57% and 41% of patients, respectively. Patients with high EUTOS risk scores achieved CCyR and MMR significantly later than patients with low EUTOS risk. Probabilities of overall survival (OS) and progression-free survival for all patients at 12, 24 and 30 months was 97%, 94% and 92%, and 95%, 92% and 90%, respectively. The new EUTOS long-term survival score was validated: the OS of patients differed significantly between the three risk groups. The probability of dying in remission was 1% after 24 months. The current management of patients with tyrosine kinase inhibitors resulted in responses and outcomes in the range reported from clinical trials. These data from a large population-based, patient sample provide a solid benchmark for the evaluation of new treatment policies.Leukemia advance online publication, 23 September 2016; doi:10.1038/leu.2016.246.

Published
2017
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10. ADULTS AND CHILDREN (1-45 YEARS) WITH PH-NEGATIVE ALL HAVE ALMOST IDENTICAL OUTCOME IN RISK-STRATIFIED ANALYSIS OF NOPHO ALL2008

Author

Toft, N., Birgens, H., Abrahamsson, J., Griskevicius, L., Hallbook, H., Heyman, M., Klausen, T. W., Jonsson, O. G., Palk, K., Pruunsild, K., Quist-Paulsen, P., Vaitkeviciene, G., Vettenranta, K., Asberg, A., Frandsen, T. Leth, Marquart, H. V., Madsen, H. O., Norén-Nyström, Ulrika, Schmiegelow, K., Toft, N., Birgens, H., Abrahamsson, J., Griskevicius, L., Hallbook, H., Heyman, M., Klausen, T. W., Jonsson, O. G., Palk, K., Pruunsild, K., Quist-Paulsen, P., Vaitkeviciene, G., Vettenranta, K., Asberg, A., Frandsen, T. Leth, Marquart, H. V., Madsen, H. O., Norén-Nyström, Ulrika, and Schmiegelow, K.

Published
2016

11. Adults And Children (1-45 Years) With Ph-Negative All Have Almost Identical Outcome In Risk-Stratified Analysis Of Nopho All2008

Author

Toft, N., Birgens, H., Abrahamsson, J., Griskevicius, L., Hallböök, Helene, Heyman, M., Klausen, T. W., Jonsson, O. G., Palk, K., Pruunsild, K., Quist-Paulsen, P., Vaitkeviciene, G., Vettenranta, K., Asberg, A., Frandsen, T. Leth, Marquart, H. V., Madsen, H. O., Noren-Nystrom, U., Schmiegelow, K., Toft, N., Birgens, H., Abrahamsson, J., Griskevicius, L., Hallböök, Helene, Heyman, M., Klausen, T. W., Jonsson, O. G., Palk, K., Pruunsild, K., Quist-Paulsen, P., Vaitkeviciene, G., Vettenranta, K., Asberg, A., Frandsen, T. Leth, Marquart, H. V., Madsen, H. O., Noren-Nystrom, U., and Schmiegelow, K.

Published
2016

12. The EUTOS population-based registry : incidence and clinical characteristics of 2904 CML patients in 20 European Countries

Author

Hoffmann, V. S., Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., Costeas, P., Mayer, J., Indrak, K., Everaus, H., Koskenvesa, P., Guilhot, J., Schubert-Fritschle, G., Castagnetti, F., Di Raimondo, F., Lejniece, S., Griskevicius, L., Thielen, N., Sacha, T., Hellmann, A., Turkina, A. G., Zaritskey, A., Bogdanovic, A., Sninska, Z., Zupan, I., Steegmann, J-L, Simonsson, Bengt, Clark, R. E., Covelli, A., Guidi, G., Hehlmann, R., Hoffmann, V. S., Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., Costeas, P., Mayer, J., Indrak, K., Everaus, H., Koskenvesa, P., Guilhot, J., Schubert-Fritschle, G., Castagnetti, F., Di Raimondo, F., Lejniece, S., Griskevicius, L., Thielen, N., Sacha, T., Hellmann, A., Turkina, A. G., Zaritskey, A., Bogdanovic, A., Sninska, Z., Zupan, I., Steegmann, J-L, Simonsson, Bengt, Clark, R. E., Covelli, A., Guidi, G., and Hehlmann, R.

Abstract

This population-based registry was designed to provide robust and updated information on the characteristics and the epidemiology of chronic myeloid leukemia (CML). All cases of newly diagnosed Philadelphia positive, BCR-ABL1+ CML that occurred in a sample of 92.5 million adults living in 20 European countries, were registered over a median period of 39 months. 94.3% of the 2904 CML patients were diagnosed in chronic phase (CP). Median age was 56 years. 55.5% of patients had comorbidities, mainly cardiovascular (41.9%). High-risk patients were 24.7% by Sokal, 10.8% by EURO, and 11.8% by EUTOS risk scores. The raw incidence increased with age from 0.39/100 000/year in people 20-29 years old to 1.52 in those >70 years old, and showed a maximum of 1.39 in Italy and a minimum of 0.69 in Poland (all countries together: 0.99). The proportion of Sokal and Euro score high-risk patients seen in many countries indicates that trial patients were not a positive selection. Thus from a clinical point of view the results of most trials can be generalized to most countries. The incidences observed among European countries did not differ substantially. The estimated number of new CML cases per year in Europe is about 6370.

Published
2015
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13. ANALYSIS OF TREATMENT AND OUTCOME DATA OF 2904 PATIENTS FROM THE EUTOS POPULATION-BASED REGISTRY

Author

Hoffmann, V. S., Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., Costeas, P., Mayer, J., Indrak, K., Everaus, H., Koskenvesa, P., Guilhot, J., Schubert-Fritschle, G., Castagnetti, F., di Raimondo, F., Lejniece, S., Griskevicius, L., Thielen, N., Sacha, T., Hellmann, A., Turkina, A., Zaritskey, A., Bogdanovic, A., Sninska, Z., Zupan, I., Steegmann, J. -L, Simonsson, Bengt, Clark, R., Hehlmann, R., Hoffmann, V. S., Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., Costeas, P., Mayer, J., Indrak, K., Everaus, H., Koskenvesa, P., Guilhot, J., Schubert-Fritschle, G., Castagnetti, F., di Raimondo, F., Lejniece, S., Griskevicius, L., Thielen, N., Sacha, T., Hellmann, A., Turkina, A., Zaritskey, A., Bogdanovic, A., Sninska, Z., Zupan, I., Steegmann, J. -L, Simonsson, Bengt, Clark, R., and Hehlmann, R.

Published
2015

14. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia.

Author

Deshmukh C.D., Offner F., Van Den Neste E.W., Wu K.L., Van Hoof A., Maiolino A., Pinczowski H., Zanichelli M.A., Pereira J., Larratt L., Spaner D., Howson-Jan K., Chen C.I., Cantin G., Fernandez L.A., Fraser G., Mayer J., Trneny M., Jebavy L., Bordessoule D., Lamy T., Milpied N., Truchan-Graczyk M., Eghbali H., Karsenti J.-M., Celigny P.S., Mans L., Cazin B., Gyan E., Lepretre S., Bergmann L., Tsionos K., Lokeshwar N.M., Agarwal M.B., Ross C.R., Narayanan G., Raina V., Bondarde S.A., Shah B.A., Bairey O., Tikva P., Shvidel L., Ambrosetti A., Rossi P.G.B., Angelucci E., Carella A.M., Massaia M., Zinzani P.L., Caligaris-Cappio F., Foa R., Gaidano G., della Carita A.O.M., Leone G., Santoro A., Griskevicius L., Jurgutis R., Baker B.W., Hawkins T., Corbett G.M., Ganly P., D'Souza A.B., Deptala A., Holowiecki J., Kloczko J., Skotnicki A., Zdziarska B., Kyrcz-Krzemien S., Dmoszynska A., Moreira I., Pereira A.P., Colita A., Moicean A.D., Vasilica M., Danaila C., Gheorghita E., Pavlov V.V., Rossiev V.A., Konstantinova T., Samoilova O.S., Novgorod N., Shelekhova T., Zaritsky A.Y., Abdulkadyrov K.M., Zyuzgin I.S., Pristupa A.S., Loscertales J., Vidal J.B., de Mallorca P., Gonzalez M., Ortuno F., Giraldo P., Nathwani A., Agrawal S.G., Rule S., Dearden C.E., Bloor A.J., Haynes A., Singer C., Boclek R.G., Bosserman L.D., Chan D., Davidson S.J., Dichmann R.A., Farber C., Hart L., Hermann R., Hu E., Janakiraman N., Jonas W., Liem K.D., Mcintyre R.E., O'Brien S., Patel G., Rado T., Schilder R., Smith S.E., Stock W., Turturro F., Venugopal P., Anderson T.C., Berry W., Boyd T.E., Byrd J., Cooper M., Flinn I., Gersh R., Gordon D., Guzley G.J., Wilks S.T., Klein A., Krauss J.C., Lister J., Mandell L., Molina A., Cooper B., Pendergrass K.B., Reeder C., Savin M.A., Spitzer G., Tuscano J.M., vanDeventer H., Eradat H.A., Masood A., Mena R., Awan F.T., Hillmen P., Hellmann A., Robak T., Hughes S.G., Trone D., Shannon M., Flinn I.W., Byrd J.C., Riveros D., Pavlovsky S., Iastrebner C.M., Carney D.A., Deveridge S., Durrant S., Hahn U.H., Hertzberg M., Leahy M.F., Ma D., Marlton P., Mulligan S., Opat S.S., Tiley C., Wickham N.W., Cannell P., Gatalano J., Catalano J., Cull G., To L.B., Hopfinger G., Jager U., Linkesch W., Petzer A., Schwarzmeier J., Steurer M., Greil R., Bememan Z., Bosly A., Bron D., Janssens A., Deshmukh C.D., Offner F., Van Den Neste E.W., Wu K.L., Van Hoof A., Maiolino A., Pinczowski H., Zanichelli M.A., Pereira J., Larratt L., Spaner D., Howson-Jan K., Chen C.I., Cantin G., Fernandez L.A., Fraser G., Mayer J., Trneny M., Jebavy L., Bordessoule D., Lamy T., Milpied N., Truchan-Graczyk M., Eghbali H., Karsenti J.-M., Celigny P.S., Mans L., Cazin B., Gyan E., Lepretre S., Bergmann L., Tsionos K., Lokeshwar N.M., Agarwal M.B., Ross C.R., Narayanan G., Raina V., Bondarde S.A., Shah B.A., Bairey O., Tikva P., Shvidel L., Ambrosetti A., Rossi P.G.B., Angelucci E., Carella A.M., Massaia M., Zinzani P.L., Caligaris-Cappio F., Foa R., Gaidano G., della Carita A.O.M., Leone G., Santoro A., Griskevicius L., Jurgutis R., Baker B.W., Hawkins T., Corbett G.M., Ganly P., D'Souza A.B., Deptala A., Holowiecki J., Kloczko J., Skotnicki A., Zdziarska B., Kyrcz-Krzemien S., Dmoszynska A., Moreira I., Pereira A.P., Colita A., Moicean A.D., Vasilica M., Danaila C., Gheorghita E., Pavlov V.V., Rossiev V.A., Konstantinova T., Samoilova O.S., Novgorod N., Shelekhova T., Zaritsky A.Y., Abdulkadyrov K.M., Zyuzgin I.S., Pristupa A.S., Loscertales J., Vidal J.B., de Mallorca P., Gonzalez M., Ortuno F., Giraldo P., Nathwani A., Agrawal S.G., Rule S., Dearden C.E., Bloor A.J., Haynes A., Singer C., Boclek R.G., Bosserman L.D., Chan D., Davidson S.J., Dichmann R.A., Farber C., Hart L., Hermann R., Hu E., Janakiraman N., Jonas W., Liem K.D., Mcintyre R.E., O'Brien S., Patel G., Rado T., Schilder R., Smith S.E., Stock W., Turturro F., Venugopal P., Anderson T.C., Berry W., Boyd T.E., Byrd J., Cooper M., Flinn I., Gersh R., Gordon D., Guzley G.J., Wilks S.T., Klein A., Krauss J.C., Lister J., Mandell L., Molina A., Cooper B., Pendergrass K.B., Reeder C., Savin M.A., Spitzer G., Tuscano J.M., vanDeventer H., Eradat H.A., Masood A., Mena R., Awan F.T., Hillmen P., Hellmann A., Robak T., Hughes S.G., Trone D., Shannon M., Flinn I.W., Byrd J.C., Riveros D., Pavlovsky S., Iastrebner C.M., Carney D.A., Deveridge S., Durrant S., Hahn U.H., Hertzberg M., Leahy M.F., Ma D., Marlton P., Mulligan S., Opat S.S., Tiley C., Wickham N.W., Cannell P., Gatalano J., Catalano J., Cull G., To L.B., Hopfinger G., Jager U., Linkesch W., Petzer A., Schwarzmeier J., Steurer M., Greil R., Bememan Z., Bosly A., Bron D., and Janssens A.

Abstract

Summary: Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B-cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open-label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty-seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression-free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.Copyright © 2014 John Wiley & Sons Ltd.

Published
2015

15. The Eutos Population-Based Registry : Evaluation of Baseline Characteristics and First Treatment Choices Of 2983 Newly Diagnosed Chronic Myeloid Leukemia (Cml) Patients from 20 European Countries

Author

Lindoerfer, D., Hoffmann, V. S., Rosti, G., Castagnetti, F., Saussele, S., Guilhot, J., Simonsson, Bengt, Steegmann, J. L., Mayer, J., Indrak, K., Turkina, A. G., Zaritskey, A., Labar, B., Zupan, I. P., Thielen, N., Clark, R. E., Thaler, J., Melanthiou, F., Everaus, H., Porkka, K., Bogdanovic, A. D., Schubert-Fritschle, G., Panagiotidis, P., Masszi, T., Lejniece, S., Griskevicius, L., Hellmann, A., Prejzner, W., Sacha, T., Almeida, A., Dyagil, I., Colita, A., Mihaylov, G., Hehlmann, R., Hasford, J., Baccarani, M., Lindoerfer, D., Hoffmann, V. S., Rosti, G., Castagnetti, F., Saussele, S., Guilhot, J., Simonsson, Bengt, Steegmann, J. L., Mayer, J., Indrak, K., Turkina, A. G., Zaritskey, A., Labar, B., Zupan, I. P., Thielen, N., Clark, R. E., Thaler, J., Melanthiou, F., Everaus, H., Porkka, K., Bogdanovic, A. D., Schubert-Fritschle, G., Panagiotidis, P., Masszi, T., Lejniece, S., Griskevicius, L., Hellmann, A., Prejzner, W., Sacha, T., Almeida, A., Dyagil, I., Colita, A., Mihaylov, G., Hehlmann, R., Hasford, J., and Baccarani, M.

Published
2014

16. The Eutos Population Based Registry - Incidences of CML Across Europe

Author

Hoffmann, V., Lindoerfer, D., Thaler, J., Labar, B., Melanthiou, F., Mayer, J., Everaus, H., Porkka, K., Guillhot, J., Schubert-Fritschle, G., Castagnetti, F., Lejniece, S., Griskevicius, L., Thielen, N., Hellmann, A., Turkina, A., Zaritskey, A., Bogdanovic, A. D., Indrak, K., Zupan, I. P., Casado, L. F., Simonsson, Bengt, Clark, R. E., Hehlmann, R., Hasford, J., Baccarani, M., Hoffmann, V., Lindoerfer, D., Thaler, J., Labar, B., Melanthiou, F., Mayer, J., Everaus, H., Porkka, K., Guillhot, J., Schubert-Fritschle, G., Castagnetti, F., Lejniece, S., Griskevicius, L., Thielen, N., Hellmann, A., Turkina, A., Zaritskey, A., Bogdanovic, A. D., Indrak, K., Zupan, I. P., Casado, L. F., Simonsson, Bengt, Clark, R. E., Hehlmann, R., Hasford, J., and Baccarani, M.

Published
2014

17. TREOSULFAN BASED CONDITIONING PRIOR TO ALLOGENEIC STEM CELL TRANSPLANTATION (HSCT) FOR ACUTE MYELOGENOUS LEUKEMIA (AML): A RETROSPECTIVE ANALYSIS FROM THE ALWP OF THE EBMT

Author

Nagler, A., Labopin, M., Shimoni, A., Beelen, D., Kyrcz-Krzemien, S., Schufer-Eckart, K., Volin, L., Hallek, M., Griskevicius, L., Blau, I. Wolfgang, Casper, J., Ciceri, F., Mohty, M., Nagler, A., Labopin, M., Shimoni, A., Beelen, D., Kyrcz-Krzemien, S., Schufer-Eckart, K., Volin, L., Hallek, M., Griskevicius, L., Blau, I. Wolfgang, Casper, J., Ciceri, F., and Mohty, M.

Published
2014

18. TREOSULFAN BASED CONDITIONING PRIOR TO ALLOGENEIC STEM CELL TRANSPLANTATION (HSCT) FOR ACUTE MYELOGENOUS LEUKEMIA (AML): A RETROSPECTIVE ANALYSIS FROM THE ALWP OF THE EBMT

Author

Nagler, A., Labopin, M., Shimoni, A., Beelen, D., Kyrcz-Krzemien, S., Schufer-Eckart, K., Volin, L., Hallek, M., Griskevicius, L., Blau, I. Wolfgang, Casper, J., Ciceri, F., Mohty, M., Nagler, A., Labopin, M., Shimoni, A., Beelen, D., Kyrcz-Krzemien, S., Schufer-Eckart, K., Volin, L., Hallek, M., Griskevicius, L., Blau, I. Wolfgang, Casper, J., Ciceri, F., and Mohty, M.

Published
2014

19. Bosutinib Versus Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia: Results From the BELA Trial

Author

Cortes, J, Kim, D, Kantarjian, H, Brümmendorf, T, Dyagil, I, Griskevicius, L, Malhotra, H, Powell, C, Gogat, K, Countouriotis, A, GAMBACORTI PASSERINI, C, GAMBACORTI PASSERINI, CARLO, Cortes, J, Kim, D, Kantarjian, H, Brümmendorf, T, Dyagil, I, Griskevicius, L, Malhotra, H, Powell, C, Gogat, K, Countouriotis, A, GAMBACORTI PASSERINI, C, and GAMBACORTI PASSERINI, CARLO

Abstract

PURPOSE Bosutinib is an oral Src/Abl tyrosine kinase inhibitor. The phase III Bosutinib Efficacy and Safety in Newly Diagnosed Chronic Myeloid Leukemia (BELA) trial compared bosutinib with imatinib in newly diagnosed, chronic-phase chronic myeloid leukemia (CML). PATIENTS AND METHODS A total of 502 patients were randomly assigned 1:1 to bosutinib 500 mg per day or imatinib 400 mg per day. Results The complete cytogenetic response (CCyR) rate at 12 months was not different for bosutinib (70%; 95% CI, 64% to 76%) versus imatinib (68%; 95% CI, 62% to 74%; two-sided P = .601); therefore, the study did not achieve its primary end point. The major molecular response (MMR) rate at 12 months was higher with bosutinib (41%; 95% CI, 35% to 47%) compared with imatinib (27%; 95% CI, 22% to 33%; two-sided P < .001). Time to CCyR and MMR was faster with bosutinib compared with imatinib (two-sided P < .001 for both). On-treatment transformation to accelerated/blast phase occurred in four patients (2%) on bosutinib compared with 10 patients (4%) on imatinib. A total of three CML-related deaths occurred on the bosutinib arm compared with eight on the imatinib arm. The safety profiles of bosutinib and imatinib were distinct; GI and liver-related events were more frequent with bosutinib, whereas neutropenia, musculoskeletal disorders, and edema were more frequent with imatinib. CONCLUSION This ongoing trial did not meet its primary end point of CCyR at 12 months, despite the observed higher MMR rate at 12 months, faster times to CCyR and MMR, fewer on-treatment transformations to accelerated/blast phase, and fewer CML-related deaths with bosutinib compared with imatinib. Each drug had a distinct safety profile.

Published
2012

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