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Completed Phase 1 Interventional

A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL)

ClinicalTrials.gov ID: NCT00991133

Public ClinicalTrials.gov record NCT00991133. 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 Sep 3, 2026, 1:14 AM EDT

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, Open-Label, Multi-Center Safety and Tolerability Pilot Combination Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) in First Relapse

Brief summary

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

This is an open-label study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine to assess this 5-drug treatment's safety and tolerability in pediatric patients with first relapse Acute Lymphoblastic Leukemia (ALL).

Study identification

NCT ID
NCT00991133
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Genzyme, a Sanofi Company
Industry
Enrollment
8 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Year to 30 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
Sep 30, 2009
Primary completion
Mar 31, 2011
Completion
Mar 31, 2011
Last update posted
Apr 29, 2015

2009 – 2011

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
Children's Hospital Los Angeles Los Angeles California 90027
The Children's Hospital Aurora Colorado 80045
Children's Healthcare of Atlanta Atlanta Georgia 30322
Children's Memorial Hospital Chicago Illinois 60614
Dana Farber Cancer Institute Boston Massachusetts 02115
Seattle Children's Hospital Seattle Washington 98105

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 NCT00991133, 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 29, 2015 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00991133 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →