Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00044889
First received: September 6, 2002
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.

This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed < one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study - an Induction phase and a Consolidation phase.


Condition Intervention Phase
Acute Myelogenous Leukemia
Drug: clofarabine (IV formulation)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Resource links provided by NLM:


Further study details as provided by Sanofi:

Estimated Enrollment: 40
Study Start Date: May 2002
Study Completion Date: March 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
  • Diagnosis of AML according to FAB classification
  • Must not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory
  • A Karnofsky Performance Status (KPS) of greater than or equal to 60.
  • If female of childbearing potential, patients must have a negative serum or urine pregnancy test within 7 days of study enrollment. Men and women with reproductive potential must use as an effective contraceptive method while enrolled in the study. Patients must have contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.
  • Signed, written informed consent.
  • Ability to comply with study procedures and follow-up examinations.
  • Adequate organ function as indicated by specific laboratory values (defined in the protocol), obtained within two weeks prior to registration.
  • Classified as AML FAB M3 (Acute Promyelocytic leukemia) and have been treated with at least 2 regimens (a retinoic acid containing regimen and an arsenic trioxide containing regimen) before being considered for this study.

Exclusion Criteria:

  • note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
  • Received previous treatment with CLOFARABINE.
  • Received more than two previous induction regimens or cycles for the treatment of AML.
  • Relapsed > 1 year.
  • Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
  • Are pregnant or lactating.
  • Have psychiatric disorders that would interfere with consent, study participation or follow-up.
  • Are receiving any other chemotherapy or corticosteroids. Patients must be off previous therapy for at least two weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment.
  • Have any other severe concurrent disease.
  • Have symptomatic CNS involvement.
  • Have chronic myelogenous leukemia (CML) in lymphoid blast crisis).
  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: NCT00044889

Locations
United States, California
Los Angeles, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Jacksonville, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New York
Buffalo, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Texas
Houston, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00044889     History of Changes
Other Study ID Numbers: CLO221
Study First Received: September 6, 2002
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
CLO221
clolar

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Clofarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014