Clofarabine in Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00028418
Recruitment Status : Completed
First Posted : January 9, 2002
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

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
Hematologic Neoplasms Lymphoproliferative Disorders Leukemia Leukemia, Lymphocytic, Chronic Drug: Clofarabine 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 Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
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 : February 1999
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Clofarabine
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00028418

United States, Texas
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Hagop M. Kantarjian, M.D. M.D. Anderson Cancer Center Identifier: NCT00028418     History of Changes
Other Study ID Numbers: FD-R-1972-01
DM93-036; FD-R-001972-01
First Posted: January 9, 2002    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: November 2001

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

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoproliferative Disorders
Hematologic Neoplasms
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Neoplasms by Site
Hematologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents