Study Evaluating Sorafenib Added to Standard Primary Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Less Than 60 Years of Age

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia (AML)
• Interventions: Drug: placebo; Drug: sorafenib

• Registration Number: NCT00893373
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-06
• Primary Completion: 2011-11
• Study Completion: 2014-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Induction, Consolidation and Maintenance plus Placebo
Sorafenib	sorafenib	Induction, Consolidation and Maintenance plus Sorafenib 2x 400 mg/d

Primary Outcome Measures

Name	Time	Method
Event-free survival	36 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	36 months
Toxicity	36 months
Rate of complete remissions	12 weeks

Trial Locations

Locations (9)

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, Germany

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany