Clofarabine in Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.

First Received: January 4, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00028418

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Official Title:	Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Clofarabine

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

Study ID Numbers:	FD-R-1972-01, DM93-036; FD-R-001972-01
Study First Received:	January 4, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00028418 History of Changes
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:

Clofarabine
Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Hematologic Neoplasms
Immune System Diseases
Antineoplastic Agents
Hematologic Diseases
Pharmacologic Actions

Leukemia
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Leukemia, B-Cell
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 30, 2009