Regular Article CLINICAL TRIALS AND OBSERVATIONS Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy
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Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy Hartmut Döhner, Michael Lübbert, Walter Fiedler, Loic Fouillard, Alf Haaland, Joseph M. Brandwein, Stephane Lepretre, Oumedaly Reman, Pascal Turlure, Oliver G. Ottmann, Carsten Müller-Tidow, Alwin Krämer, Emmanuel Raffoux, Konstanze Döhner, Richard F. Schlenk, Florian Voss, Tillmann Taube, Holger Fritsch, and Johan Maertens
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CLINICAL TRIALS AND OBSERVATIONS A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome
We previously reported the feasibility of clofarabine and cytarabine combinations in AML. Questions remain as to (1) the therapeutic advantage of this combination and (2) the role of lower doses of clofarabine and cytarabine in older patients. We have conducted an adaptively randomized study of lower-dose clofarabine with or without low-dose cytarabine in previously untreated patients with AML ...
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Complete remission and long-term survival rates are low for older adults treated for acute myeloid leukemia (AML). Because of favorable phase 2 data using mitoxantrone and etoposide, we conducted a phase 3 study (SWOG-9333) in which patients over 55 years of age with previously untreated AML were randomized to receive mitoxantrone (10 mg/m2 per day 5) and etoposide (100 mg/m2 per day 5) [ME], o...
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