Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)

May 26, 2022 updated by: Genzyme, a Sanofi Company

A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic 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 Lymphoblastic Leukemia (ALL.)

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 lymphoblastic leukemia (ALL). Eligible patients must be in second 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

60

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, 90027
        • Children's Hospital
      • Orange County, California, United States
        • Children's Hospital
      • San Diego, California, United States
        • Children's Hospital
    • Colorado
      • Denver, Colorado, United States, 80218
        • Children's Hospital
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins Children's Center
    • Missouri
      • Saint Louis, Missouri, United States
        • Children's Hospital
    • New York
      • New York, New York, United States
        • Memorial Sloan-Kettering
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Children's Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital
    • Tennessee
      • Memphis, Tennessee, United States
        • St. Jude Children's Research Hospital
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Cook's Children's Medical Center
      • Houston, Texas, United States
        • Texas Children's Cancer Center
      • Houston, Texas, United States
        • The University of Texas M.D. Anderson Cancer Center

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 (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a diagnosis of ALL 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 second 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.
  • Have a Karnofsky Performance Status (KPS) of >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.
  • Be able to comply with study procedures and follow-up examinations.
  • 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 had a recent (<30 days) history of fungal or serious bacterial infection or who are receiving therapeutic antibiotics.
  • 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 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, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or pancreas.
  • Have symptomatic CNS involvement.
  • Febrile neutropenia at time of study entry.
  • Have received a hematologic stem cell transplant (HSCT) within the previous 3 months or have active GVHD (greater than or equal to Grade 2).

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
  • Masking: NONE

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)

January 1, 2006

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 (ACTUAL)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLO212

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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