Clofarabine in Chronic Lymphocytic Leukemia - Tabular View

Tracking Information

First Received Date ^ICMJE

January 4, 2002

Last Updated Date

June 23, 2005

Start Date ^ICMJE

February 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00028418 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Clofarabine in Chronic Lymphocytic Leukemia

Official Title ^ICMJE

Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies

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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study

Condition ^ICMJE

Hematologic Neoplasms
Lymphoproliferative Disorders
Leukemia
Leukemia, Lymphocytic, Chronic

Intervention ^ICMJE

Drug: Clofarabine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

100

Completion Date

March 2001

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00028418

Responsible Party

Study ID Numbers ^ICMJE

FD-R-1972-01, DM93-036; FD-R-001972-01

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Hagop M. Kantarjian, M.D.

M.D. Anderson Cancer Center

Information Provided By

FDA Office of Orphan Products Development

Verification Date

November 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP