Clofarabine in Chronic Lymphocytic Leukemia
Recruitment status was Active, not recruiting
This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias. Clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against lymphoproliferative disorders. Thus, it is hoped that this drug will be more active and less toxic than similar drugs.
Leukemia, Lymphocytic, Chronic
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies|
|Study Start Date:||February 1999|
|Estimated Study Completion Date:||March 2001|
The first group of patients will be treated at the starting dose level of 2 mg/m2 over 1 hour daily for 5 days. Dosage escalation will be permitted in individual patients if no toxicity occurred during the preceding course. Subsequent dose escalations will be by 50% until Grade 2 toxicity, then by 35% until the maximum tolerated dose.
|United States, Texas|
|University of Texas M. D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Hagop M. Kantarjian, M.D.||M.D. Anderson Cancer Center|