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

March 17, 2014 updated by: Genzyme, a Sanofi Company

A Phase II, Open-Label Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Jacksonville, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Buffalo, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Texas
      • Houston, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

September 6, 2002

First Submitted That Met QC Criteria

September 6, 2002

First Posted (Estimate)

September 9, 2002

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLO221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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