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Clofarabine in Chronic Lymphocytic Leukemia

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00028418
Collaborator
(none)
100
Enrollment
1
Location
60.9
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Allocation:
Non-Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies
Study Start Date :
Feb 1, 1999
Study Completion Date :
Mar 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas M. D. Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Hagop M. Kantarjian, M.D., M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00028418
    Other Study ID Numbers:
    • FD-R-1972-01
    • DM93-036; FD-R-001972-01
    First Posted:
    Jan 9, 2002
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Nov 1, 2001
    Keywords provided by , ,
    Acute Leukemia
    Chronic Lymphocytic Leukemia
    Antineoplastic Agents
    Nucleosides
    Dose-Response Relationship, Drug
    Cladribine
    Fludarabine
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphocytic, Chronic, B-Cell
    Leukemia, Lymphoid
    Hematologic Neoplasms
    Lymphoproliferative Disorders
    Clofarabine

    Study Results

    No Results Posted as of Mar 25, 2015