Clofarabine in Chronic Lymphocytic Leukemia

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00028418
• Other study ID #: FD-R-1972-01
• Secondary ID: DM93-036; FD-R-0
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2002
• Last updated: March 24, 2015
• Start date: February 1999
• Est. completion date: March 2004

Study information

• Verified date: November 2001
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Diagnosis of chronic lymphocytic leukemia

• Diagnosis of other acute leukemia

• At least 2 weeks since prior chemotherapy, immunotherapy, and/or radiotherapy

• Recovered from toxic effects of prior therapy

• Bilirubin no greater than 2 mg/dL

• Creatinine no greater than 1.5 mg/dL

Exclusion criteria:

• Candidate for treatment of higher efficacy or priority

• Pregnant or nursing

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Leukemia
• Leukemia, Lymphocytic, Chronic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoproliferative Disorders

Intervention

Drug:
• Clofarabine

Locations

Country	Name	City	State
United States	University of Texas M. D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States,