Oral Clofarabine Study in Patients With Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00299156|
Recruitment Status : Completed
First Posted : March 6, 2006
Results First Posted : September 18, 2015
Last Update Posted : November 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia||Drug: Clofarabine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Oral Clofarabine in Myelodysplastic Syndrome (MDS)|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Oral Clofarabine
10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
Starting dose 10 mg (Group 1) or 20 mg (Group 2) as tablets once a day for 5 days in a row and repeated every 4-8 weeks. Each 4-8 week period is a cycle.
- Participants With a Complete Remission (CR) [ Time Frame: After 3 courses of treatment, up to 24 weeks. ]
Complete Remission (CR): Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L).
Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment.
Hematologic Improvement: meets all criteria for CR except for platelet recovery to >100 x 109/L.
Clinical Benefit: Platelets increase by 50% and to above 30 x 109/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 109/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 x 109/L.
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): NCT00299156
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Hagop Kantarjian, MD||M.D. Anderson Cancer Center|