Investigation of Clofarabine in Acute Leukemias

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00098033
First received: December 2, 2004
Last updated: March 24, 2015
Last verified: December 2004
  Purpose

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 Intervention Phase
Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Drug: clofarabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 64
Study Start Date: September 2002
Estimated Study Completion Date: September 2005
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00098033     History of Changes
Other Study ID Numbers: 2127
Study First Received: December 2, 2004
Last Updated: March 24, 2015
Health Authority: United States: Food and Drug Administration

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, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Bone Marrow Diseases
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Clofarabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015