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

Bob Löwenberg, T Pabst, J Maertens, Patrycja Gradowska, BJ Biemond, O Spertini, E Vellenga, L Griskevicius, LW Tick, Mojca Jongen - Lavrencic, MV Kooy, MC Vekemans, W van der Velden, Berna Beverloo, L Michaux, C Graux, D Deeren, O de Weerdt, JWJ van Esser, M BargetziSK Klein, A Gadisseur, PE Westerweel, H Veelken, M Gregor, T Silzle, D van Lammeren-Venema, I Moors, D Breems, M Hoogendoorn, M Legdeur, T Fischer, J Kuball, Jan Cornelissen, K Porkka, G Juliusson, P Meyer, M Hoglund, BT Gjertsen, J Janssen, G Huls, J Passweg, J Cloos, Peter Valk, C van Elssen, MG Manz, Y Floisand, GJ Ossenkoppele

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32 Citations (Scopus)


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 (15mg 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% 6 2% standard error and overall survival, 54% 6 2% at 4 years for both arms) although in an exploratory post hoc analysis, a lenalidomide benefit was suggested in SRSF2-mutant AML.

Original languageEnglish
Pages (from-to)1110-1121
Number of pages12
JournalBlood advances
Issue number4
Publication statusPublished - 22 Feb 2021

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© 2021 by The American Society of Hematology 1110.

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