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

Phase 2
21 Years
Not Enrolling
Leukemia, Myelocytic, Acute, Pediatric

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Trial Information

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

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.

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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

Related Keywords:

  • Leukemia, Myelocytic, Acute, Pediatric
  • CLO222
  • clolar
  • Pediatric Acute Myelogenous Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



University of Nebraska Medical Center Omaha, Nebraska  68198-3330
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Texas Children's Cancer Center Houston, Texas  77030-2399
University of Connecticut Health Center Farmington, Connecticut  06360-7106
Arkansas Children's Hospital Little Rock, Arkansas  72202-3591
Children's Hospital Los Angeles, California  90027
Children's Hospital Denver, Colorado  80218
Children's Memorial Hospital Chicago, Illinois  60614
Johns Hopkins Children's Center Baltimore, Maryland  
Children's Hospital St. Louis, Missouri  
Memorial Sloan-Kettering New York, New York  
Children's Hospital Philadelphia, Pennsylvania  
Cook's Children's Medical Center Fort Worth, Texas  76104
The University of Texas M.D. Anderson Cancer Center Houston, Texas  
Children's Medical Center Dallas, Texas