- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042354
Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
March 4, 2015 updated by: Genzyme, a Sanofi Company
A Phase II, Open Label Study of Clofarabine in Pediatric 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.
The purpose of this study is to determine whether Clofarabine is safe and effective in the treatment of Acute Myelogenous Leukemia (AML.)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a non-randomized, open label, Phase II study of Clofarabine in pediatric patients with refractory or relapsed acute myelogenous leukemia (AML).
Eligible patients must be in first or subsequent relapse or be refractory.
Forty eligible patients will be enrolled in a Fleming 2-stage sequential study design in order to better assess the efficacy and safety of clofarabine in this patient population.
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
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Hospital
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California
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Los Angeles, California, United States, 90027
- Children's Hospital
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Orange County, California, United States
- Children's Hospital
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San Diego, California, United States
- Children's Hospital
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Colorado
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Denver, Colorado, United States
- Children's Hospital
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Connecticut
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Hartford, Connecticut, United States, 06106
- University of Connecticut Health Center
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Illinois
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Chicago, Illinois, United States, 60614
- Children's Memorial Hospital
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Maryland
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Baltimore, Maryland, United States, 21231
- Johns Hopkins Children's Center
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Missouri
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St. Louis, Missouri, United States
- Children's Hospital
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Nebraska
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Omaha, Nebraska, United States, 67198
- University of Nebraska Medical Center
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New York
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New York, New York, United States
- Memorial Sloan-Kettering
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- Children's Hospital
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital
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Tennessee
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Memphis, Tennessee, United States
- St. Jude Children's Research Hospital
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Texas
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Dallas, Texas, United States
- Children's Medical Center
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Fort Worth, Texas, United States, 76104
- Cook's Children's Medical Center
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Houston, Texas, United States
- Texas Children's Cancer Center
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Houston, Texas, United States
- The University of Texas M.D. Anderson Cancer Center
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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
No older than 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a diagnosis of AML according to FAB classification with greater than or equal to 25% blasts in the bone marrow.
- Be less than or equal to 21 years old at time of initial diagnosis.
- Not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory. Where an alternative therapy has been shown to prolong survival in an analogous population, this should be offered to the patient prior to discussing this study.
- Patients with acute promyelocytic leukemia (M3) must 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.
- Have a Karnofsky Performance Status (KPS) of greater than or equal to 70.
- Provide signed, written informed consent from parent or guardian and assent from patients greater than or equal to 7 years old according to local IRB and institutional requirements.
- Have adequate organ function as indicated by the following laboratory values, obtained within 2 weeks prior to registration: Serum bilirubin less than or equal to 1.5 x ULN; AST and ALT less than or equal to 5 x ULN; Serum Creatinine less than 2 x ULN for age. ULN= Institutional Upper Limit of Normal
Exclusion Criteria:
- Received previous treatment with Clofarabine.
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
- Are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control (i.e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.
- Have psychiatric disorders that would interfere with consent, study participation, or follow up.
- Are receiving any other chemotherapy. Patients must have been off previous therapy for at least 2 weeks (with the exception of intrathecal therapy, which is allowed up to 24hrs prior to 1st dose of study drug) and must have recovered from acute toxicity of all previous therapy prior to enrollment. Treatment may start earlier, following consultation with the ILEX Medical Monitor, if there is evidence of disease relapse prior to that time.
- Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Have symptomatic CNS involvement.
- Febrile neutropenia at time of study entry.
- Known or suspected fungal infection (ie. patients on parenteral antifungal therapy).
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
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)
August 1, 2004
Study Registration Dates
First Submitted
July 26, 2002
First Submitted That Met QC Criteria
July 31, 2002
First Posted (Estimate)
August 1, 2002
Study Record Updates
Last Update Posted (Estimate)
March 5, 2015
Last Update Submitted That Met QC Criteria
March 4, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLO222
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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