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1. Addition of the nuclear export inhibitor selinexor to standard intensive treatment for elderly patients with acute myeloid leukemia and high risk myelodysplastic syndrome

Author

Janssen, J. J. W. M., Löwenberg, B., Manz, M., Biemond, B. J., Westerweel, P. E., Klein, S. K., Fehr, M., Sinnige, H. A. M., Efthymiou, A., Legdeur, M. C. J. C., Pabst, T., Gregor, M., van der Poel, M. W. M., Deeren, D., Tick, L. W., Jongen-Lavrencic, M., van Obbergh, F., Boersma, R. S., de Weerdt, O., Chalandon, Y., Heim, D., Spertini, O., van Sluis, G., Graux, C., Stüssi, G., van Norden, Y., and Ossenkoppele, G. J.

Published
2022
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2. Postremission Consolidation by Autologous Hematopoietic Cell Transplantation (HCT) for Acute Myeloid Leukemia in First Complete Remission (CR) and Negative Implications for Subsequent Allogeneic HCT in Second CR: A Study by the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation (EBMT)

Author

Passweg, J.R., Labopin, M., Christopeit, M., Cornelissen, J., Pabst, T., Socié, G., Russel, N., Yakoub-Agha, I., Blaise, D., Gedde-Dahl, T., Labussière-Wallet, H., Malladi, R., Forcade, E., Maury, S., Polge, E., Lanza, F., Gorin, N.C., Mohty, M., and Nagler, A.

Published
2020
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5. Prospective validation of the prognostic relevance of CD34+CD38- AML stem cell frequency in the HOVON-SAKK132 trial.

Author

Ngai, L.L., Hanekamp, D., Janssen, F, Carbaat-Ham, J., Hofland, M.A.M.A., Fayed, M.M.H.E., Kelder, A., Oudshoorn-van Marsbergen, L., Scholten, W.J., Snel, A.N., Bachas, C., Tettero, J.M., Breems, D.A., Fischer, T., Gjertsen, B.T., Griškevičius, L., Juliusson, G., Loosdrecht, A.A. van de, Maertens, J.A., Manz, M.G., Pabst, T., Passweg, J.R., Porkka, K., Valk, P.J.M., Gradowska, P., Löwenberg, B., Leeuw, D.C. de, Janssen, J.J.W.M., Ossenkoppele, G.J., Cloos, J., Ngai, L.L., Hanekamp, D., Janssen, F, Carbaat-Ham, J., Hofland, M.A.M.A., Fayed, M.M.H.E., Kelder, A., Oudshoorn-van Marsbergen, L., Scholten, W.J., Snel, A.N., Bachas, C., Tettero, J.M., Breems, D.A., Fischer, T., Gjertsen, B.T., Griškevičius, L., Juliusson, G., Loosdrecht, A.A. van de, Maertens, J.A., Manz, M.G., Pabst, T., Passweg, J.R., Porkka, K., Valk, P.J.M., Gradowska, P., Löwenberg, B., Leeuw, D.C. de, Janssen, J.J.W.M., Ossenkoppele, G.J., and Cloos, J.

Abstract

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Published
2023

6. Etoposide plus cytarabine versus cyclophosphamide or melphalan in busulfan-based preparative regimens for autologous stem cell transplantation in adults with acute myeloid leukemia in first complete remission: a study from the Acute Leukemia Working Party of the EBMT.

Author

Sanz, J., Labopin, M., Pabst, T., Versluis, J., Gorkom, G. van, Meijer, E., Gedde-Dahl, T., Montoro, J., Arcese, W., Pérez-Simón, J.A., Schaap, N.P.M., Maertens, J., Vrhovac, R., Lanza, F., Gorin, N.C., Mohty, M., Ciceri, F., Sanz, J., Labopin, M., Pabst, T., Versluis, J., Gorkom, G. van, Meijer, E., Gedde-Dahl, T., Montoro, J., Arcese, W., Pérez-Simón, J.A., Schaap, N.P.M., Maertens, J., Vrhovac, R., Lanza, F., Gorin, N.C., Mohty, M., and Ciceri, F.

Abstract

Contains fulltext : 299983.pdf (Publisher’s version ) (Closed access), We retrospectively compared the impact of the conditioning regimen in adult patients with acute myeloid leukemia (AML) in first complete remission (CR1) that received high-dose myeloablative chemotherapy followed by autologous stem cell transplantation (ASCT) from 2010 to 2021 with either high-dose cytarabine, etoposide and busulfan (BEA), busulfan with cyclophosphamide (BUCY) or busulfan and high-dose melphalan (BUMEL) registered in the EBMT database. Overall 1560 patients underwent ASCT, of which 156, 1143 and 261 received BEA, BUCY and BUMEL, respectively. Compared to BUCY and BUMEL, BEA patients were younger (p < 0.001) and less frequently had NPM1 mutations (p = 0.03). Transplant outcomes at 5 years with BEA, BUCY and BUMEL were: cumulative incidence of relapse 41.8%, 46.6% and 51.6%; non-relapse mortality (NRM) 1.5%, 5.2% and 7.3%; probability of leukemia-free survival (LFS) 56.7%, 48.2% and 41.1%; and overall survival (OS) 71.3%, 62.3% and 56%, respectively. In multivariable analysis the BEA regimen showed significant improvement in OS compared to BUCY (hazard ratio [HR] 0.65; 95% CI, 0.42-0.83; p = 0.048) and BUMEL (HR 0.59; 95% CI, 0.37-0.94; p = 0.029). In conclusion, high-dose myeloablative combination chemotherapy with BEA offered improved outcomes compared to classical BUCY or BUMEL in patients with AML in CR1 undergoing ASCT., 01 november 2023

Published
2023

7. Age and sex associate with outcome in older AML and high risk MDS patients treated with 10-day decitabine

Author

Hilberink, Jacobien R., van Zeventer, Isabelle A., Chitu, D. A., Pabst, T., Klein, Saskia K., Stussi, G., Griskevicius, Laimonas, Valk, P. J.M., Cloos, J., van de Loosdrecht, Arjan A., Breems, D., van Lammeren-Venema, D., Boersma, R., Jongen-Lavrencic, M., Fehr, M., Hoogendoorn, Mels, Manz, Markus G., Söhne, M., van Marwijk Kooy, R., Deeren, D., van der Poel, Marjolein W.M., Legdeur, M. C., Tick, L., Chalandon, Y., Ammatuna, Emanuele, Blum, S., Löwenberg, Bob, Ossenkoppele, Gert J., Huls, G., Hilberink, Jacobien R., van Zeventer, Isabelle A., Chitu, D. A., Pabst, T., Klein, Saskia K., Stussi, G., Griskevicius, Laimonas, Valk, P. J.M., Cloos, J., van de Loosdrecht, Arjan A., Breems, D., van Lammeren-Venema, D., Boersma, R., Jongen-Lavrencic, M., Fehr, M., Hoogendoorn, Mels, Manz, Markus G., Söhne, M., van Marwijk Kooy, R., Deeren, D., van der Poel, Marjolein W.M., Legdeur, M. C., Tick, L., Chalandon, Y., Ammatuna, Emanuele, Blum, S., Löwenberg, Bob, Ossenkoppele, Gert J., and Huls, G.

Abstract

Treatment choice according to the individual conditions remains challenging, particularly in older patients with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS). The impact of performance status, comorbidities, and physical functioning on survival is not well defined for patients treated with hypomethylating agents. Here we describe the impact of performance status (14% ECOG performance status 2), comorbidity (40% HCT-comorbidity index ≥ 2), and physical functioning (41% short physical performance battery < 9 and 17% ADL index < 6) on overall survival (OS) in 115 older patients (age ≥ 66 years) treated on a clinical trial with a 10-day decitabine schedule. None of the patient-related variables showed a significant association with OS. Multivariable analysis revealed that age > 76 years was significantly associated with reduced OS (HR 1.58; p = 0.043) and female sex was associated with superior OS (HR 0.62; p = 0.06). We further compared the genetic profiles of these subgroups. This revealed comparable mutational profiles in patients younger and older than 76 years, but, interestingly, revealed significantly more prevalent mutated ASXL1, STAG2, and U2AF1 in male compared to female patients. In this cohort of older patients treated with decitabine age and sex, but not comorbidities, physical functioning or cytogenetic risk were associated with overall survival.

Published
2023

9. Correction: Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

Author

Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., A von dem Borne, P., Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, C., Huls, G., Janssen, J. J. J. W., Jaspers, A., Jongen-Lavrencic, M., de Jongh, E., Klein, S. K., van der Klift, M., van Marwijk Kooy, M., Maertens, J., Michaux, L., van der Poel, M. W. M., van Rhenen, A., Tick, L., Valk, P., Vekemans, M. C., van der Velden, W. J. F. M., de Weerdt, O., Pabst, T., Manz, M., and Löwenberg, B.

Published
2020
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10. Comparative value of post-remission treatment in cytogenetically normal AML subclassified by NPM1 and FLT3-ITD allelic ratio

Author

Versluis, J, in ‘t Hout, F E M, Devillier, R, van Putten, W L J, Manz, M G, Vekemans, M -C, Legdeur, M -C, Passweg, J R, Maertens, J, Kuball, J, Biemond, B J, Valk, P J M, van der Reijden, B A, Meloni, G, Schouten, H C, Vellenga, E, Pabst, T, Willemze, R, Löwenberg, B, Ossenkoppele, G, Baron, F, Huls, G, and Cornelissen, J J

Published
2017
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14. Comparative therapeutic value of post-remission approaches in patients with acute myeloid leukemia aged 40–60 years

Author

Cornelissen, J J, Versluis, J, Passweg, J R, van Putten, W L J, Manz, M G, Maertens, J, Beverloo, H B, Valk, P J M, van Marwijk Kooy, M, Wijermans, P W, Schaafsma, M R, Biemond, B J, Vekemans, M-C, Breems, D A, Verdonck, L F, Fey, M F, Jongen-Lavrencic, M, Janssen, J J W M, Huls, G, Kuball, J, Pabst, T, Graux, C, Schouten, H C, Gratwohl, A, Vellenga, E, Ossenkoppele, G, and Löwenberg, B

Published
2015
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16. Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

Author

Ossenkoppele, G.J., Breems, D.A., Stuessi, G., Norden, Y. van, Bargetzi, M., Biemond, B.J., Borne, P.A. von dem, Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, C., Huls, G., Janssen, J.J.J.W., Jaspers, A., Jongen-Lavrencic, M., Jongh, E. de, Klein, S.K., Klift, M. van der, Kooy, M.V., Maertens, J., Micheaux, L., Poel, M.W.M. van der, Rhenen, A. van, Tick, L., Valk, P., Vekemans, M.C., Velden, W.J.F.M. van der, Weerdt, O. de, Pabst, T., Manz, M., Lowenberg, B., Havelange, Moors, I., Obberg, F. van, Maertens, J.A., Hodossy, B., Vansteenweghen, S., Lammertijn, L., Sonet, A., Triffet, A., Gjertsen, B.T., Passweg, J., Heim, D., Giovanni, S., Betticher, D., Spertini, O., Gregor, M., Hess, U., Manz, M.G., Loosdrecht, A. van de, Janssen, J.J.W.M., Esser, J.W.J. van, Brouwer, R.E., Lammeren-Venema, D. van, Levin, M.D., Tick, L.W., Legdeur, M.C.J.C., Vellenga, E., Hoogendoorn, M., Veelken, J.H., Schouten, H.C., Cornelissen, J., Wouters, B., Raaijmakers, H.G.M., Kuball, J., Dutch-Belgian Hemato-Oncology, Swiss Grp Clinical Canc Res SAKK, Stem Cell Aging Leukemia and Lymphoma (SALL), Guided Treatment in Optimal Selected Cancer Patients (GUTS), Clinical Haematology, CCA - Cancer Treatment and Quality of Life, CCA - Cancer Treatment and quality of life, Hematology laboratory, Hematology, Department of History, International Institute of Social Studies, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Hematologie (9), UCL - SSS/DDUV - Institut de Duve, UCL - SSS/DDUV/MEXP - Médecine expérimentale, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (MGD) Service d'hématologie, and UCL - (SLuc) Service d'hématologie

Subjects
0301 basic medicine, Cancer Research, medicine.medical_specialty, medicine.medical_treatment, Phases of clinical research, HIGH-DOSE LENALIDOMIDE, ACUTE MYELOID-LEUKEMIA, THERAPY, 03 medical and health sciences, 0302 clinical medicine, Older patients, SDG 3 - Good Health and Well-being, Internal medicine, medicine, 610 Medicine & health, Adverse effect, Lenalidomide, Chemotherapy, business.industry, Intensive treatment, Myeloid leukemia, Hematology, ADULTS, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5], Cytarabine, business, medicine.drug
Abstract

Contains fulltext : 225470.pdf (Publisher’s version ) (Closed access) More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n = 222) to receive standard chemotherapy ("3 + 7") with or without lenalidomide at a dose of 20 mg/day 1-21. In the second cycle, patients received cytarabine 1000 mg/m(2) twice daily on days 1-6 with or without lenalidomide (20 mg/day 1-21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).

Published
2020
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18. Addition of the nuclear export inhibitor selinexor to standard intensive treatment for elderly patients with acute myeloid leukemia and high risk myelodysplastic syndrome.

Author

UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Janssen, J J W M, Löwenberg, B, Manz, M, Biemond, B J, Westerweel, P E, Klein, S K, Fehr, M, Sinnige, H A M, Efthymiou, A, Legdeur, M C J C, Pabst, T, Gregor, M, van der Poel, M W M, Deeren, D, Tick, L W, Jongen-Lavrencic, M, van Obbergh, F, Boersma, R S, de Weerdt, O, Chalandon, Y, Heim, D, Spertini, O, van Sluis, G, Graux, Carlos, Stüssi, G, van Norden, Y, Ossenkoppele, G J, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Janssen, J J W M, Löwenberg, B, Manz, M, Biemond, B J, Westerweel, P E, Klein, S K, Fehr, M, Sinnige, H A M, Efthymiou, A, Legdeur, M C J C, Pabst, T, Gregor, M, van der Poel, M W M, Deeren, D, Tick, L W, Jongen-Lavrencic, M, van Obbergh, F, Boersma, R S, de Weerdt, O, Chalandon, Y, Heim, D, Spertini, O, van Sluis, G, Graux, Carlos, Stüssi, G, van Norden, Y, and Ossenkoppele, G J

Abstract

Treatment results of AML in elderly patients are unsatisfactory. In an open label randomized phase II study, we investigated whether addition of the XPO1 inhibitor selinexor to intensive chemotherapy would improve outcome in this population. 102 AML patients > 65 years of age (median 69 (65-80)) were randomly assigned to standard chemotherapy (3 + 7) with or without oral selinexor 60 mg twice weekly (both arms n = 51), days 1-24. In the second cycle, cytarabine 1000 mg/m twice daily, days 1-6 with or without selinexor was given. CR/CRi rates were significantly higher in the control arm than in the investigational arm (80% (95% C.I. 69-91%) vs. 59% (45-72%; p = 0.018), respectively). At 18 months, event-free survival was 45% for the control arm versus 26% for the investigational arm (Cox-p = 0.012) and overall survival 58% vs. 33%, respectively (p = 0.009). AML and infectious complications accounted for an increased death rate in the investigational arm. Irrespective of treatment, MRD status after two cycles appeared to be correlated with survival. We conclude that the addition of selinexor to standard chemotherapy does negatively affect the therapeutic outcome of elderly AML patients. (Netherlands Trial Registry number NL5748 (NTR5902), www.trialregister.nl ).

Published
2022

26. Addition of lenalidomide to intensive treatment in younger and middle-aged adults with newly diagnosed AML: the HOVON-SAKK-132 trial

Author

Lowenberg, B., Pabst, T., Maertens, J., Gradowska, P., Biemond, B.J., Spertini, O., Vellenga, E., Griskevicius, L., Tick, L.W., Jongen-Lavrencic, M., Kooy, M.V., Vekemans, M.C., Velden, W.J.F.M. van der, Beverloo, B., Michaux, L., Graux, C., Deeren, D., Weerdt, O. de, Esser, J.W.J. van, Bargetzi, M., Klein, S.K., Gadisseur, A., Westerweel, P.E., Veelken, H., Gregor, M., Silzle, T., Lammeren-Venema, D. van, Moors, I., Breems, D.A., Hoogendoorn, M., Legdeur, M.C.J.C., Fischer, T., Kuball, J., Cornelissen, J., Porkka, K., Juliusson, G., Meyer, P., Hoglund, M., Gjertsen, B.T., Janssen, J.J.W.M., Huls, G., Passweg, J., Cloos, J., Valk, P.J.M., Elssen, C.H.M.J. van, Manz, M.G., Floisand, Y., Ossenkoppele, G.J., Dutch-Belgian Hemato-Oncology Coop, Swiss Grp Clinical Canc Res SAKK, Clinical Haematology, CCA - Cancer Treatment and Quality of Life, Hematology, Clinical Genetics, Dutch-Belgian Hemato-Oncology Cooperative Group, Swiss Group for Clinical Cancer Research (SAKK), Internal medicine, VU University medical center, Hematology laboratory, AII - Cancer immunology, CCA - Cancer Treatment and quality of life, MUMC+: MA Hematologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: MA Med Staf Artsass Interne Geneeskunde (9), UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (MGD) Service d'hématologie, UCL - (SLuc) Service d'hématologie, Stem Cell Aging Leukemia and Lymphoma (SALL), and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Subjects
Oncology, Clinical Trials and Observations, Phases of clinical research, 0302 clinical medicine, Autologous stem-cell transplantation, hemic and lymphatic diseases, Medicine and Health Sciences, ELDERLY-PATIENTS, Lenalidomide, LENALIDOMIDE, Remission Induction, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, Chemotherapy regimen, 3. Good health, CYTARABINE, Leukemia, Myeloid, Acute, 030220 oncology & carcinogenesis, Life Sciences & Biomedicine, medicine.drug, Adult, medicine.medical_specialty, Adolescent, HIGH-DOSE LENALIDOMIDE, MINIMAL RESIDUAL DISEASE, ACUTE MYELOID-LEUKEMIA, Transplantation, Autologous, 03 medical and health sciences, Young Adult, All institutes and research themes of the Radboud University Medical Center, SEQUENTIAL AZACITIDINE, Internal medicine, AZACITIDINE PLUS LENALIDOMIDE, AZACITIDINE PLUS, medicine, Humans, COMBINATION, Aged, Science & Technology, business.industry, Minimal residual disease, Transplantation, Regimen, Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5], Cytarabine, Human medicine, business, 030215 immunology
Abstract

Lenalidomide, an antineoplastic and immunomodulatory drug, has therapeutic activity in acute myeloid leukemia (AML), but definitive studies about its therapeutic utility have been lacking. In a phase 3 study, we compared 2 induction regimens in newly diagnosed patients age 18 to 65 years with AML: idarubicine-cytarabine (cycle 1) and daunorubicin and intermediate-dose cytarabine (cycle 2) without or with lenalidomide (15 mg orally on days 1-21). One final consolidation cycle of chemotherapy or autologous stem cell transplantation (auto-SCT) or allogeneic SCT (allo-SCT) was provided according to a prognostic risk and minimal residual disease (MRD)-adapted approach. Event-free survival (EFS; primary end point) and other clinical end points were assessed. A second random assignment in patients in complete response or in complete response with incomplete hematologic recovery after cycle 3 or auto-SCT involved 6 cycles of maintenance with lenalidomide (10 mg on days 1-21) or observation. In all, 392 patients were randomly assigned to the control group, and 388 patients were randomly assigned to lenalidomide induction. At a median follow-up of 41 months, the study revealed no differences in outcome between the treatments (EFS, 44% ± 2% standard error and overall survival, 54% ± 2% at 4 years for both arms) although in an exploratory post hoc analysis, a lenalidomide benefit was suggested in SRSF2-mutant AML. In relation to the previous Dutch-Belgian Hemato-Oncology Cooperative Group and Swiss Group for Clinical Cancer Research (HOVON-SAKK) studies that used a similar 3-cycle regimen but did not pursue an MRD-guided approach, these survival estimates compare markedly more favorably. MRD status after cycle 2 lost prognostic value in intermediate-risk AML in the risk-adjusted treatment context. Maintenance with lenalidomide showed no apparent effect on relapse probability in 88 patients randomly assigned for this part of the study. ispartof: BLOOD ADVANCES vol:5 issue:4 pages:1110-1121 ispartof: location:United States status: published

Published
2020
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27. Addition of lenalidomide to intensive treatment in younger and middle-aged adults with newly diagnosed AML: the HOVON-SAKK-132 trial

Author

Lowenberg, B., Pabst, T., Maertens, Johan, Gradowska, Patrycja, Biemond, Bart J., Spertini, Olivier, Velden, W.J.F.M. van der, Janssen, J.J.W.M., Floisand, Yngvar, Ossenkoppele, G.J., Lowenberg, B., Pabst, T., Maertens, Johan, Gradowska, Patrycja, Biemond, Bart J., Spertini, Olivier, Velden, W.J.F.M. van der, Janssen, J.J.W.M., Floisand, Yngvar, and Ossenkoppele, G.J.

Abstract

Contains fulltext : 231621.pdf (Publisher’s version ) (Open Access)

Published
2021

28. Inferior outcome of addition of the aminopeptidase inhibitor tosedostat to standard intensive treatment for elderly patients with aml and high risk mds

Author

Janssen, J. (Jeroen), Löwenberg, B. (Bob), Manz, M. (Markus), Bargetzi, M. (Mario), Biemond, B.J. (Bart), Borne, P.A.K. (Peter) von dem, Breems, D.A. (Dimitri), Brouwer, R.E. (Rolf), Chalandon, Y. (Yves), Deeren, D. (Dries), Efthymiou, A. (Anna), Gjertsen, B.-T. (Bjørn-Tore), Graux, C. (Carlos), Gregor, M. (Michael), Heim, D. (Dominik), Hess, U. (Urs), Hoogendoorn, M. (Mels), Jaspers, A. (Aurelie), Jie, A. (Asiong), Jongen-Lavrencic, M. (Mojca), Klein, S. (Saskia), Klift, M. (Marjolein) van der, Kuball, J. (Jürgen), van Lammeren - Venema, D. (Danielle), Legdeur, M.C.J.C. (M. C J C), Loosdrecht, A.A. (Arjan) van de, Maertens, J. (Johan), Kooy, M.M. (Marinus van Marwijk), Moors, I. (Ine), Nijziel, M.R. (Marten), van Obbergh, F. (Florence), Oosterveld, M. (Margriet), Pabst, T. (Thomas), van der Poel, M. (Marjolein), Sinnige, H. (Harm), Spertini, O. (Olivier), Terpstra, W. (Wim), Tick, L.W. (Lidwine), Velden, W.J.F.M. (Walter) van der, Vekemans, M.-C. (Marie-Christiane), Vellenga, E. (Edo), Weerdt, O. (Okke) de, Westerweel, P. (Peter), Stussi, G. (Georg), Norden, Y. (Yvette) van, Ossenkoppele, G.J. (Gert), Janssen, J. (Jeroen), Löwenberg, B. (Bob), Manz, M. (Markus), Bargetzi, M. (Mario), Biemond, B.J. (Bart), Borne, P.A.K. (Peter) von dem, Breems, D.A. (Dimitri), Brouwer, R.E. (Rolf), Chalandon, Y. (Yves), Deeren, D. (Dries), Efthymiou, A. (Anna), Gjertsen, B.-T. (Bjørn-Tore), Graux, C. (Carlos), Gregor, M. (Michael), Heim, D. (Dominik), Hess, U. (Urs), Hoogendoorn, M. (Mels), Jaspers, A. (Aurelie), Jie, A. (Asiong), Jongen-Lavrencic, M. (Mojca), Klein, S. (Saskia), Klift, M. (Marjolein) van der, Kuball, J. (Jürgen), van Lammeren - Venema, D. (Danielle), Legdeur, M.C.J.C. (M. C J C), Loosdrecht, A.A. (Arjan) van de, Maertens, J. (Johan), Kooy, M.M. (Marinus van Marwijk), Moors, I. (Ine), Nijziel, M.R. (Marten), van Obbergh, F. (Florence), Oosterveld, M. (Margriet), Pabst, T. (Thomas), van der Poel, M. (Marjolein), Sinnige, H. (Harm), Spertini, O. (Olivier), Terpstra, W. (Wim), Tick, L.W. (Lidwine), Velden, W.J.F.M. (Walter) van der, Vekemans, M.-C. (Marie-Christiane), Vellenga, E. (Edo), Weerdt, O. (Okke) de, Westerweel, P. (Peter), Stussi, G. (Georg), Norden, Y. (Yvette) van, and Ossenkoppele, G.J. (Gert)

Abstract

Treatment results of AML in elderly patients are unsatisfactory. We hypothesized that addition of tosedostat, an aminopeptidase inhibitor, to intensive chemotherapy may improve outcome in this population. After establishing a safe dose in a run-in phase of the study in 22 patients, 231 eligible patients with AML above 65 years of age (median 70, range 66–81) were randomly assigned in this open label randomized Phase II study to receive standard chemotherapy (3+7) with or without tosedostat at the selected daily dose of 120 mg (n = 116), days 1–21. In the second cycle, patients received cytarabine 1000 mg/m2 twice daily on days 1-6 with or without tosedostat. CR/CRi rates in the 2 arms were not significantly different (69% (95% C.I. 60–77%) vs 64% (55–73%), respectively). At 24 months, event-free survival (EFS) was 20% for the standard arm versus 12% for the tosedostat arm (Cox-p = 0.01) and overall survival (OS) 33% vs 18% respectively (p = 0.006). Infectious complications accounted for an increased early death rate in the tosedostat arm. Atrial fibrillation wa

Published
2021
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29. Inferior outcome of addition of the aminopeptidase inhibitor tosedostat to standard intensive treatment for elderly patients with aml and high risk mds

Author

Janssen, J, Löwenberg, Bob, Manz, M, Bargetzi, M, Biemond, B, van den Borne, P, Breems, D, Brouwer, R, Chalandon, Y, Deeren, D, Efthymiou, A, Gjertsen, BT, Graux, C, Gregor, M, Heim, D, Hess, U, Hoogendoorn, M, Jaspers, A, Jie, A, Jongen - Lavrencic, Mojca, Klein, S, van der Klift, Maarten, Kuball, J, van Lammeren-Venema, D, Legdeur, MC, van de Loosdrecht, A, Maertens, J, Kooy, MM, Moors, I, Nijziel, M, van Obbergh, F, Oosterveld, M, Pabst, T, Poel, M, Sinnige, H, Spertini, O, Terpstra, W, Tick, L, van der Velden, W, Vekemans, MC, Vellenga, E, de Weerdt, O, Westerweel, P, Stüssi, G, van Norden, Yvette, Ossenkoppele, G, Janssen, J, Löwenberg, Bob, Manz, M, Bargetzi, M, Biemond, B, van den Borne, P, Breems, D, Brouwer, R, Chalandon, Y, Deeren, D, Efthymiou, A, Gjertsen, BT, Graux, C, Gregor, M, Heim, D, Hess, U, Hoogendoorn, M, Jaspers, A, Jie, A, Jongen - Lavrencic, Mojca, Klein, S, van der Klift, Maarten, Kuball, J, van Lammeren-Venema, D, Legdeur, MC, van de Loosdrecht, A, Maertens, J, Kooy, MM, Moors, I, Nijziel, M, van Obbergh, F, Oosterveld, M, Pabst, T, Poel, M, Sinnige, H, Spertini, O, Terpstra, W, Tick, L, van der Velden, W, Vekemans, MC, Vellenga, E, de Weerdt, O, Westerweel, P, Stüssi, G, van Norden, Yvette, and Ossenkoppele, G

Abstract

Treatment results of AML in elderly patients are unsatisfactory. We hypothesized that addition of tosedostat, an aminopeptidase inhibitor, to intensive chemotherapy may improve outcome in this population. After establishing a safe dose in a run-in phase of the study in 22 patients, 231 eligible patients with AML above 65 years of age (median 70, range 66–81) were randomly assigned in this open label randomized Phase II study to receive standard chemotherapy (3+7) with or without tosedostat at the selected daily dose of 120 mg (n = 116), days 1–21. In the second cycle, patients received cytarabine 1000 mg/m2 twice daily on days 1-6 with or without tosedostat. CR/CRi rates in the 2 arms were not significantly different (69% (95% C.I. 60–77%) vs 64% (55–73%), respectively). At 24 months, event-free survival (EFS) was 20% for the standard arm versus 12% for the tosedostat arm (Cox-p = 0.01) and overall survival (OS) 33% vs 18% respectively (p = 0.006). Infectious complications accounted for an increased early death rate in the tosedostat arm. Atrial fibrillation was more common in the tosedostat arm as well. The results of the present study show that the addition of tosedostat to standard chemotherapy does negatively affect the therapeutic outcome of elderly AML patients.

Published
2021

30. 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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40. Clinical, molecular, and prognostic significance of WHO type inv(3)(q21q26.2)/t(3;3)(q21;q26.2) and various other 3q abnormalities in acute myeloid leukemia: A study of 6,515 cases of AML: V27

Author

Gröschel, S., Lugthart, S., Beverloo, B. H., Kayser, S., Valk, P. J., Van Zelderen-Bhola, S. L., Ossenkoppele, G.-J., Vellenga, E., van den Berg-de Ruiter, E., Schanz, U., Verhoef, G., Ferrant, A., Köhne, C.-H., Pfreundschuh, M., Horst, H.-A., Koller, E., von Lilienfeld-Toal, M., Bentz, M., Ganser, A., Schlegelberger, B., Jotterand, M., Krauter, J., Pabst, T., Theobald, M., Schlenk, R. F., Delwel, R., Döhner, K., Löwenberg, B., and Döhner, H.

Published
2010

41. Bortezomib (Velcade®)-Thalidomide-Dexamethasone (VTD) versus Thalidomide-Dexamethasone to treat multiple myeloma (MM) patients progressing or relapsing after autologous transplantation: the MMVAR trial, a study from the myeloma subcommittee of the Chronic Leukemia Working Party of the EBMT: 221

Author

Garderet, L., Iacobelli, S., Moreau, P., Onida, F., Koenecke, C., Pabst, T., Doyen, C., Crawley, C., Hajek, R., Linkesch, W., Harousseau, J. L., Michallet, M., Doran, Z., de Witte, T., Niederwieser, D., Gahrton, G., and Morris, C.

Published
2009

42. Bortezomib (Velcade®)-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone to treat multiple myeloma patients progressing or relapsing after autologous transplantation: the MMVAR trial, a study from the myeloma subcommittee of the Chronic Leukemia Working Party of the EBMT

Author

Garderet, L., Iacobelli, S., Moreau, P., Onida, F., Könecke, C., Pabst, T., Doyen, C., Crawley, C., Hajek, R., Linkesch, W., Harousseau, J.-L., Michallet, M., Doran, Z., de Witte, T., Niederwieser, D., Gahrton, G., and Morris, C.

Published
2008

44. 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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45. Positron emission tomography guided omission of radiotherapy in early-stage unfavorable Hodgkin Lymphoma: Final results of the international, randomized Phase III HD17 trial by the German Hodgkin Study Group

Author

Borchmann, P., Kobe, C., Pluetschow, A., Greil, R., Meissner, J., Topp, M. S., Ostermann, H., Dierlamm, J., Mohm, J., Thiemer, J., Soekler, M., Kerkhoff, A., Ahlborn, M., Halbsguth, T., Martin, S., Keller, U., Balabanov, S., Pabst, T., Vogelhuber, M., Huettmann, A., Wilhem, M., Zijlstra, J. M., Moccia, A., Broeckelmann, P. J., von Tresckow, B., Fuchs, M., Eich, H., Baues, C., Hallek, M., Diehl, V, Dietlein, M., Engert, A., Borchmann, P., Kobe, C., Pluetschow, A., Greil, R., Meissner, J., Topp, M. S., Ostermann, H., Dierlamm, J., Mohm, J., Thiemer, J., Soekler, M., Kerkhoff, A., Ahlborn, M., Halbsguth, T., Martin, S., Keller, U., Balabanov, S., Pabst, T., Vogelhuber, M., Huettmann, A., Wilhem, M., Zijlstra, J. M., Moccia, A., Broeckelmann, P. J., von Tresckow, B., Fuchs, M., Eich, H., Baues, C., Hallek, M., Diehl, V, Dietlein, M., and Engert, A.

Published
2020

46. Correction: Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

Author

UCL - (SLuc) Centre du cancer, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'hématologie, UCL - SSS/DDUV/MEXP - Médecine expérimentale, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., A von dem Borne, P., Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, Carlos, Huls, G., Janssen, J. J. J. W., Jaspers, A., Jongen-Lavrencic, M., de Jongh, E., Klein, S. K., van der Klift, M., van Marwijk Kooy, M., Maertens, J., Michaux, L., van der Poel, M. W. M., van Rhenen, A., Tick, L., Valk, P., Vekemans, Marie-Christiane, van der Velden, W. J. F. M., de Weerdt, O., Pabst, T., Manz, M., Löwenberg, B., Havelange, Violaine, Sonet, Anne, UCL - (SLuc) Centre du cancer, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'hématologie, UCL - SSS/DDUV/MEXP - Médecine expérimentale, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., A von dem Borne, P., Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, Carlos, Huls, G., Janssen, J. J. J. W., Jaspers, A., Jongen-Lavrencic, M., de Jongh, E., Klein, S. K., van der Klift, M., van Marwijk Kooy, M., Maertens, J., Michaux, L., van der Poel, M. W. M., van Rhenen, A., Tick, L., Valk, P., Vekemans, Marie-Christiane, van der Velden, W. J. F. M., de Weerdt, O., Pabst, T., Manz, M., Löwenberg, B., Havelange, Violaine, and Sonet, Anne

Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

47. 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

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