A Phase 1-2 Study of Azacitidine in Combination With Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia
Overview
- Phase
- Phase 1
- Intervention
- Lenalidomide
- Conditions
- Acute Myeloid Leukemia (AML)
- Sponsor
- Stanford University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Compete Remission (CR) Rate
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study has a phase 1 and a phase 2 component.
In phase 1, the objective is to determine the maximum tolerated dose (MTD) of lenalidomide when after azacitidine.
In phase 2, the objective is to determine the efficacy of the combination treatment.
Detailed Description
The treatment regimen in this study is 7 day courses of azacitidine 75 mg/m2 followed by a 21-day courses of lenalidomide. For the primary objective, each 28-day cycle was repeated for a total of up to 6 cycles. Study completion was defined as 18 cycles of treatment, disease progression, or death. In phase 1, the objective was to determine the maximum tolerated dose (MTD) of lenalidomide 5 mg, 10 mg, 25 mg or 50 mg, when administered after azacitidine. In phase 2, the objective was to assess the efficacy of MTD lenalidomide administered after azacitidine, in up to six 28-day cycles.
Investigators
Bruno C. Medeiros
Assistant Professor
Stanford University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Azacitidine followed by lenalidomide
Dose escalation then dose expansion
Intervention: Lenalidomide
Azacitidine followed by lenalidomide
Dose escalation then dose expansion
Intervention: Azacitidine
Outcomes
Primary Outcomes
Compete Remission (CR) Rate
Time Frame: 12 months
Compete Remission (CR) includes subjects with CR but incomplete recovery of blood counts (CRi). CR was assessed according to the European LeukemiaNet (ELN) guidelines, and is defined as the absence of clonal lymphocytes in the peripheral blood.
Secondary Outcomes
- Time to CR(18 weeks)
- 4-week Survival Rate(28 days)
- Maximum Tolerated Dose (MTD) of Lenalidomide(15 months)
- Time to PR(36 weeks)
- OS of Responders(88 weeks (median))
- Remission Duration(26 months)
- Overall Response Rate (ORR)(26 months)
- Overall Survival (OS)(88 weeks (median))