Phase 1-2 of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)
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|ClinicalTrials.gov Identifier: NCT00890929|
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : October 20, 2014
Last Update Posted : June 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML) Adult Acute Myeloblastic Leukemia||Drug: Lenalidomide Drug: Azacitidine||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1-2 Study of Azacitidine in Combination With Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2012|
Experimental: Azacitidine followed by lenalidomide
Dose escalation then dose expansion
5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle
- 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.
- 4-week Survival Rate [ Time Frame: 28 days ]"Early death" was assessed as death within 28 days of the start of treatment
- Maximum Tolerated Dose (MTD) of Lenalidomide [ Time Frame: 15 months ]The maximum tolerated dose (MTD) of lenalidomide was determined in study phase 1, for use in study Phase 2 (not conducted). The outcome is reported as the dose of lenalidomide that represents the MTD.
- Remission Duration [ Time Frame: 26 months ]Responses and remission were assessed according to the ELN guidelines.
- Overall Response Rate (ORR) [ Time Frame: 26 months ]ORR includes subjects with CR, CRi, and partial response (PR). Responses were assessed according to the ELN guidelines.
- Overall Survival (OS) [ Time Frame: 88 weeks (median) ]OS from the start of treatment was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.
- Time to CR [ Time Frame: 18 weeks ]CR includes subjects with CR but incomplete recovery of blood counts (CRi). Responses were assessed according to the ELN guidelines.
- Time to PR [ Time Frame: 36 weeks ]Responses were assessed according to the ELN guidelines.
- OS of Responders [ Time Frame: 88 weeks (median) ]OS from the start of treatment of responders (per ELN guidelines) was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890929
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Bruno Carneiro de Medeiros||Stanford University|
|Principal Investigator:||Daniel Aaron Pollyea||Stanford University|