5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination with azacitidine to patients with MDS or AML.
The goal of Phase 2 of this study is to learn if the combination dose of azacitidine and lenalidomide found in Phase 1 can help to control MDS and/or AML.
The safety of this drug combination will be studied in both Phases.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of the Combination of 5-azacitidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)|
- Maximum Dose Tolerated (MTD) of Lenalidomide in Combination with 5-azacytidine (5-aza) in Participants with Leukemia [ Time Frame: 3-8 week cycles ] [ Designated as safety issue: Yes ]If 1 participant develops grade III-IV non-hematological toxicity, 3 more patients accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, doses of the combination at which this occurs considered too toxic.
- Response Rate of Lenalidomide in Combination with 5-azacytidine (5-aza) in Participants with Leukemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]Response defined as CR or CRp for AML or any response for myelodysplastic syndrome (MDS) using IWG-06 criteria. CR is complete remission and CRp is CR with incomplete platelet recovery.
|Study Start Date:||December 2009|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: 5-Azacytidine + Lenalidomide
5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
75 mg/m^2 IV daily x 5 days on days 1 to 5.
Other Names:Drug: Lenalidomide
Starting dose 10 mg orally daily x 5 days on days 6 to 10.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01038635
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Guillermo Garcia-Manero, MD||M.D. Anderson Cancer Center|