Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)
The goal of this clinical research study is to determine the effectiveness of alemtuzumab in patients with aplastic anemia, MDS, or T-Cell large granular lymphocytic leukemia. The safety of alemtuzumab will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Pilot Study Of Alemtuzumab In Patients With Low Or INT-1 Risk Myelodysplastic Syndrome (MDS), Aplastic Anemia (AA), Or T-Cell Large Granular Lymphocytic Leukemia (T-LGL)|
- Overall Response [ Time Frame: Every 2 months ] [ Designated as safety issue: Yes ]Overall response (OR) defined as complete/partial remission for at least 4 weeks or hematologic improvement for at least 8 weeks.
|Study Start Date:||August 2010|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Alemtuzumab 10mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01191749
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Tapan Kadia, MD||UT MD Anderson Cancer Center|