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) [ Time Frame: 3-8 week cycles ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Estimated Primary Completion Date:||December 2015 (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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|Contact: Guillermo Garcia-Manero, MD||713-745-3428|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Guillermo Garcia-Manero, MD|
|Study Chair:||Guillermo Garcia-Manero, MD||UT MD Anderson Cancer Center|