Spots Global Cancer Trial Database for Clofarabine in Chronic Lymphocytic Leukemia

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Trial Identification

Brief Title: Clofarabine in Chronic Lymphocytic Leukemia

Official Title: Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies

Study ID: NCT00028418

Conditions

Hematologic Neoplasms

Lymphoproliferative Disorders

Leukemia

Leukemia, Lymphocytic, Chronic

Interventions

Clofarabine

Study Description

Brief Summary: 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.

Detailed Description: 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. Completion date provided represents the completion date of the grant per OOPD records