Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Myelogenous Leukemia
1 other identifier
interventional
40
1 country
18
Brief Summary
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.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2002
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 26, 2002
CompletedFirst Posted
Study publicly available on registry
August 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedMarch 5, 2015
March 1, 2015
July 26, 2002
March 4, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital
Los Angeles, California, 90027, United States
Children's Hospital
Orange County, California, United States
Children's Hospital
San Diego, California, United States
Children's Hospital
Denver, Colorado, United States
University of Connecticut Health Center
Hartford, Connecticut, 06106, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Johns Hopkins Children's Center
Baltimore, Maryland, 21231, United States
Children's Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, 67198, United States
Memorial Sloan-Kettering
New York, New York, United States
Children's Hospital
Philadelphia, Pennsylvania, United States
Children's Hospital
Pittsburgh, Pennsylvania, 15213, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Children's Medical Center
Dallas, Texas, United States
Cook's Children's Medical Center
Fort Worth, Texas, 76104, United States
Texas Children's Cancer Center
Houston, Texas, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 26, 2002
First Posted
August 1, 2002
Study Start
May 1, 2002
Study Completion
August 1, 2004
Last Updated
March 5, 2015
Record last verified: 2015-03