Leukemia Clinical Trial
Official title:
A Pilot Study of Lenalidomide in Adult Diamond-Blackfan Anemia Patients With Red Blood Cell Transfusion-Dependent Anemia
This is a single-center, single arm, open-label study of oral lenalidomide monotherapy
administered to red blood cell (RBC) transfusion dependent adult subjects with
Diamond-Blackfan Anemia (DBA).
Primary Objective: To evaluate the erythroid response rate as measured by rate of red blood
cell transfusion independence (MDS IWG 2000 Criteria will be applied) Secondary Objective:
1)To evaluate the tolerability and safety profile of lenalidomide in patients with DBA and
other inherited marrow failure syndromes 2) To correlate response to lenalidomide with
biologic surrogates of DBA including ribosomal protein mutation status, ex vivo erythroid
colony growth, and microarray gene expression
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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