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

B. Lowenberg*, T. Pabst, J. Maertens, P. Gradowska, B.J. Biemond, O. Spertini, E. Vellenga, L. Griskevicius, L.W. Tick, M. Jongen-Lavrencic, M.V. Kooy, M.C. Vekemans, W.J.F.M. van der Velden, B. Beverloo, L. Michaux, C. Graux, D. Deeren, O. de Weerdt, J.W.J. van Esser, M. BargetziS.K. Klein, A. Gadisseur, P.E. Westerweel, H. Veelken, M. Gregor, T. Silzle, D. Van Lammeren-Venema, I. Moors, D.A. Breems, M. Hoogendoorn, M.C.J.C. Legdeur, T. Fischer, J. Kuball, J. Cornelissen, K. Porkka, G. Juliusson, P. Meyer, M. Hoglund, B.T. Gjertsen, J.J.W.M. Janssen, G. Huls, J. Passweg, J. Cloos, P.J.M. Valk, C.H.M.J. van Elssen, M.G. Manz, Y. Floisand, G.J. Ossenkoppele, Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON), Swiss Group for Clinical Cancer Research (SAKK)

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


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.
Original languageEnglish
Pages (from-to)1110-1121
Number of pages12
JournalBlood advances
Issue number4
Publication statusPublished - 23 Feb 2021



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