NCT00028418

Clofarabine in Chronic Lymphocytic Leukemia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hematologic Neoplasms
• Lymphoproliferative Disorders
• Leukemia
• Leukemia, Lymphocytic, Chronic

Interventions

Type	Name	Description
DRUG	Clofarabine

Timeline

• Start date: 1999-02-01
• Completion: 2004-03-01
• First posted: 2002-01-09
• Last updated: 2015-03-25

Locations

1 site across 1 country: United States