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Completed Phase 1Phase 2 Interventional Results available

A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.

ClinicalTrials.gov ID: NCT00315705

Public ClinicalTrials.gov record NCT00315705. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 2, 2026, 10:50 PM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted. The purpose of the phase 1 portion of this study was to determine if clofarabine added to a combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the phase 2 portion of the study was to measure the effectiveness of the combination therapy in children with ALL.

Study identification

NCT ID
NCT00315705
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Genzyme, a Sanofi Company
Industry
Enrollment
50 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Year to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2006 (Type not available)
Primary completion
May 2010 (Actual)
Completion
May 2010 (Actual)
Last update posted
Apr 14, 2014

2006 – 2010

United States locations

U.S. sites
13
U.S. states
11
U.S. cities
12
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama — —
Children's Hospital of Los Angeles Los Angeles California — —
Rady Children's Hospital San Diego California — —
Connecticut Children's Medical Center Hartford Connecticut — —
Children's Memorial Hospital Chicago Illinois — —
St. Vincent Children's Hospital Indianapolis Indiana — —
Dana Farber Cancer Institute Boston Massachusetts — —
Children's Hospital of Michigan Detroit Michigan — —
Memorial Sloan-Kettering Cancer Center New York New York — —
New York School of Medicine New York New York — —
St. Jude Children's Research Hospital Memphis Tennessee — —
University of Texas MD Anderson Cancer Center Houston Texas — —
Seattle Children's Hospital Seattle Washington — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00315705, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 14, 2014 · Synced Nov 2, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00315705 live on ClinicalTrials.gov.

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