Sorafenib is a multikinase inhibitor which is acting on various cellular pathways involved in the genesis of acute myeloid leukemia (AML). Sorafenib is therefore a promising candidate for improvement of chemotherapy results in AML. This clinical trial evaluates the efficacy of sorafenib added to standard chemotherapy for AML in patients between 18 and 60 years of age. Patients are randomised to receive either sorafenib capsules or placebo in addition to their chemotherapy. The placebo and the sorafenib group will be compared regarding event-free survival and other clinical outcomes. An event is either treatment failure or relapse or death. According to the study hypothesis, the sorafenib group will have less events than the placebo group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
276
Standard AML chemotherapy plus sorafenib 400 mg BID
Standard AML chemotherapy plus placebo
Sozialstiftung Bamberg Klinikum am Bruderwald
Bamberg, Germany
Klinikum Bayreuth
Bayreuth, Germany
Charite Campus Benjamin Franklin
Berlin, Germany
Ev. Diakonie-Krankenhaus gGmbH Bremen
Bremen, Germany
University Hospital Dresden
Dresden, Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, Germany
Agaplesion Diakoniekrankenhaus Rotenburg
Rotenburg (Wümme), Germany
Robert-Bosch-Krankenhaus
Stuttgart, Germany
Event-free survival
Time frame: 36 months
Overall survival
Time frame: 36 months
Rate of complete remissions
Time frame: 12 weeks
Toxicity
Time frame: 36 months
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