Clofarabine in Chronic Lymphocytic Leukemia - Full Text View

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

MedlinePlus related topics:

Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for:

Fludarabine Fludarabine monophosphate Cladribine Clofarabine Vidarabine

U.S. FDA Resources

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

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

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

Study placed in the following topic categories:

Cladribine

Clofarabine

Chronic lymphocytic leukemia

Leukemia, Lymphoid

Vidarabine

Immunoproliferative Disorders

Hematologic Neoplasms

Hematologic Diseases

Fludarabine monophosphate

Leukemia

Lymphatic Diseases

Leukemia, Lymphocytic, Chronic, B-Cell

Fludarabine

Leukemia, B-Cell

Lymphoproliferative Disorders

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008

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