Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
A Phase 1-2 Study of Azacitidine in Combination With Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia
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.
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.
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