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Clofarabine in Chronic Lymphocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00028418
First received: January 4, 2002
Last updated: June 23, 2005
Last verified: November 2001
History of Changes
  Purpose

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 Intervention Phase
Hematologic Neoplasms
Lymphoproliferative Disorders
Leukemia
Leukemia, Lymphocytic, Chronic
 Drug: Clofarabine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 100
Study Start Date: February 1999
Estimated Study Completion Date: March 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028418

Locations
United States, Texas
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
FDA Office of Orphan Products Development
Investigators
Principal Investigator: Hagop M. Kantarjian, M.D. M.D. Anderson Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00028418     History of Changes
Other Study ID Numbers: FD-R-1972-01, DM93-036; FD-R-001972-01
Study First Received: January 4, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
Acute Leukemia
Chronic Lymphocytic Leukemia
Antineoplastic Agents
Nucleosides
 Dose-Response Relationship, Drug
Cladribine
Fludarabine

Additional relevant MeSH terms:
Neoplasms
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoproliferative Disorders
Hematologic Neoplasms
Neoplasms by Histologic Type
Leukemia, B-Cell
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Hematologic Diseases
Clofarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013