Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy

Author:

Döhner Hartmut1,Lübbert Michael2,Fiedler Walter3,Fouillard Loic4,Haaland Alf5,Brandwein Joseph M.6,Lepretre Stephane7,Reman Oumedaly8,Turlure Pascal9,Ottmann Oliver G.10,Müller-Tidow Carsten11,Krämer Alwin12,Raffoux Emmanuel13,Döhner Konstanze1,Schlenk Richard F.1,Voss Florian14,Taube Tillmann14,Fritsch Holger14,Maertens Johan15

Affiliation:

1. Department of Internal Medicine III, Ulm University, Ulm, Germany;

2. Department of Internal Medicine I, University of Freiburg, Freiburg, Germany;

3. Hubertus Wald University Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;

4. Centre Hospitalier René Dubos, Cergy Pontoise, France;

5. Oslo University Hospital, Oslo, Norway;

6. Princess Margaret Cancer Centre, Toronto, ON, Canada;

7. Centre de Lutte Contre Le Cancer Henri Becquerel, Rouen, France;

8. Centre Hospitalo-Universitaire de Caen, Caen, France;

9. Centre Hospitalo-Universitaire de Limoges, Limoges, France;

10. Department of Internal Medicine II, Goethe University, Frankfurt, Germany;

11. Department of Medicine A, University of Münster, Münster, Germany;

12. University of Heidelberg and German Cancer Research Center (DKFZ), Heidelberg, Germany;

13. University Hospital Saint-Louis, Assistance Publique–Hôpitaux de Paris, Paris, France;

14. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; and

15. University Hospital Gasthuisberg Leuven, Leuven, Belgium

Abstract

Key Points Volasertib plus low-dose cytarabine increased the response rate and improved survival in AML patients ineligible for intensive treatment. Volasertib plus low-dose cytarabine resulted in responses across all AML genetic subgroups and had a clinically manageable safety profile.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

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