Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Investigation of Clofarabine in Acute Leukemias

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: December 2, 2004
Last updated: March 24, 2015
Last verified: December 2004

December 2, 2004
March 24, 2015
September 2002
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00098033 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Investigation of Clofarabine in Acute Leukemias
Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias
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.

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.

Completion date provided represents the completion date of the grant per OOPD records

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myelogenous Leukemia
  • Acute Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
Drug: clofarabine
Not Provided
Cortes JE, Gandhi V, et al. Clofarabine (2-chloro-9-(deoxy-2-fluoro-b-D-arabinosfuranosyl)adenine) is active for patients with refractory or relapsed acute leukemia. #739 ASH 2002.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2005
Not Provided
  • 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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
University of Texas
Not Provided
Principal Investigator: Hagop M Kantarjian, MD M.D. Anderson Cancer Center
Study Chair: Jorge E Cortes, MD M.D. Anderson Cancer Center
FDA Office of Orphan Products Development
December 2004

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