A Double-blind, Placebo-controlled, Randomized, Multicenter Phase-II Trial to Assess the Efficacy of Sorafenib Added to Standard Primary Therapy in Patients With Newly Diagnosed AML ≤60 Years of Age
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 276
- Locations
- 9
- Primary Endpoint
- Event-free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sorafenib
Induction, Consolidation and Maintenance plus Sorafenib 2x 400 mg/d
Intervention: sorafenib (Drug)
Placebo
Induction, Consolidation and Maintenance plus Placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Event-free survival
Time Frame: 36 months
Secondary Outcomes
- Overall survival(36 months)
- Toxicity(36 months)
- Rate of complete remissions(12 weeks)