Lenalidomide and Darbepoetin in Low-Intermediate Risk Myelodysplastic Syndrome (MDS)
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|ClinicalTrials.gov Identifier: NCT01222195|
Recruitment Status : Terminated (Low accrual.)
First Posted : October 18, 2010
Results First Posted : April 26, 2011
Last Update Posted : August 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Lenalidomide Drug: Darbepoetin alfa||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Lenalidomide and Darbepoetin Alfa in Myelodysplastic Syndrome (Low to Intermediate-1 Risk Category Excluding 5q Deletion)|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
Experimental: Lenalidomide + Darbepoetin alfa
Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
10 mg/day by mouth on days 1-21 of every 28 day cycle.
Drug: Darbepoetin alfa
200 mcg subcutaneously every 2 weeks of a 28 cycle.
- Number of Patients With a Transfusion Independence Response [ Time Frame: Over six 28-day cycles (approximately 168 days) ]Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.
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): NCT01222195
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gautam Borthakur, MBBS||UT MD Anderson Cancer Center|