At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 45 enrolled
Drug / intervention
Lenalidomide +1 moredrug
Likely dose
Lenalidomide 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1-2 Study of Azacitidine in Combination With Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia
In Brief
A Phase 2 clinical trial evaluating Lenalidomide and Azacitidine for Acute Myeloid Leukemia (AML) and Adult Acute Myeloblastic Leukemia. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCelgene Corporation
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2009
First PostedApr 2009
Primary CompletionJun 2011
Study CompletionJun 2012
TodayJul 2026
First PostedApr 30, 2009
Enrollment StartApr 1, 2009
Primary CompletionJun 1, 2011
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.2 years ago
Interventions
Lenalidomidedrug
5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidinedrug
75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle