Investigation of Clofarabine in Acute Leukemias

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2004 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:

NCT00098033

First received: December 2, 2004

Last updated: June 23, 2005

Last verified: December 2004

History of Changes

Tracking Information

First Received Date ^ICMJE

December 2, 2004

Last Updated Date

June 23, 2005

Start Date ^ICMJE

September 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00098033 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Investigation of Clofarabine in Acute Leukemias

Official Title ^ICMJE

Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias

Brief Summary

The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases.

Detailed Description

The specific aims of the project are (1) conduct the phase II study of clofarabine and evaluate the antileukemic efficacy in AML, ALL, and CML-accelerated and blastic phases in terms of complete response (CR) rate, response duration, and survival; and (2) analyze the relationship between cellular uptake and retention of clofarabine triphosphate (the active metabolite), inhibition of DNA synthesis, and clinical outcome.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Chronic Myelogenous Leukemia

Intervention ^ICMJE

Drug: clofarabine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

June 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in transformation (includes CML-blastic phase and CML-accelerated phase).
No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician.
Adequate liver function (bilirubin </= 2 mg%) and renal function (creatinine </= 2 mg%).
Pregnant and lactating females not eligible.
Zubrod performance status 0-2
Adequate cardiac status
No life-threatening conditions (e.g. infections) which may cause death within 3 weeks.

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00098033

Other Study ID Numbers ^ICMJE

2127

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Hagop M Kantarjian, MD	M.D. Anderson Cancer Center
Study Chair:	Jorge E Cortes, MD	M.D. Anderson Cancer Center

Information Provided By

FDA Office of Orphan Products Development

Verification Date

December 2004

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

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