Clofarabine in Chronic Lymphocytic Leukemia

Phase 1

Completed

• Conditions: Hematologic Neoplasms; Lymphoproliferative Disorders; Leukemia; Leukemia, Lymphocytic, Chronic

• Registration Number: NCT00028418
• Lead Sponsor: M.D. Anderson Cancer Center

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

Study Timeline

• Study Start: 1999-02
• Status Verified: 2001-11
• Study First Submitted: 2002-01-04
• Study First Submitted QC: 2002-01-08
• Study First Posted: 2002-01-09
• Study Completion: 2004-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Texas M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States