Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients

NCT ID: NCT00042354

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2004-08-31

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.)

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.

Conditions

Leukemia, Myelocytic, Acute, Pediatric

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

clofarabine (IV formulation)

Intervention Type: DRUG

Eligibility Criteria

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).

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Genzyme Corporation

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Children's Hospital

Los Angeles, California, 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, United States

Children's Memorial Hospital

Chicago, Illinois, United States

Johns Hopkins Children's Center

Baltimore, Maryland, United States

Children's Hospital

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Memorial Sloan-Kettering

New York, New York, United States

Children's Hospital

Philadelphia, Pennsylvania, United States

Children's Hospital

Pittsburgh, Pennsylvania, 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, United States

Texas Children's Cancer Center

Houston, Texas, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

CLO222

Identifier Type: -

Identifier Source: org_study_id