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Investigation of Clofarabine in Acute Leukemias

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ClinicalTrials.gov Identifier: NCT00098033
Recruitment Status : Completed
First Posted : December 3, 2004
Last Update Posted : March 25, 2015
Sponsor:
Information provided by:
FDA Office of Orphan Products Development

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.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Drug: clofarabine Phase 2

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.

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


Study Type : Interventional  (Clinical Trial)
Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias
Study Start Date : September 2002
Study Completion Date : September 2005






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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098033


Sponsors and Collaborators
University of Texas
Investigators
Principal Investigator: Hagop M Kantarjian, MD M.D. Anderson Cancer Center
Study Chair: Jorge E Cortes, MD M.D. Anderson Cancer Center

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00098033     History of Changes
Other Study ID Numbers: 2127
First Posted: December 3, 2004    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: December 2004

Keywords provided by FDA Office of Orphan Products Development:
clinical
pharmacodynamics
investigational drug clofarabine
AML, ALL, CML-accelerated phase, CML-blastic phase
Chronic Myelogenous Leukemia - accelerated phase
Chronic Myelogenous Leukemia - blastic phase

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Clofarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents