Expired Study
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Denver, Colorado


Purpose:

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 summary:

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.


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).


Study is Available At:


Original ID:

CLO222


NCT ID:

NCT00042354


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sanofi


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:


Overall Contact Information

Official Name:Medical Monitor
Study Director
Genzyme, a Sanofi Company

Study Dates

Start Date:May 2002
Completion Date:August 2004
Completion Type:Actual
Verification Date:March 2015
Last Changed Date:March 4, 2015
First Received Date:July 26, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:clofarabine (IV formulation)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Genzyme, a Sanofi Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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