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NCT00991133 · ClinicalTrials.gov registry record · Phase 1
A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL)
A Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 6
- Study locations
NCT00991133 is a Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 8 participants, below the 44-participant average among 4 other Lymphoblastic Leukemia, Acute, Childhood trials with a reported enrollment target (82% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT00991133, a Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 6
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Clofarabine incorporated into a 5-drug regimen
Study Locations (6)
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- The Children's Hospital - Aurora
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Children's Memorial Hospital - Chicago
Massachusetts
- Dana Farber Cancer Institute - Boston
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00991133
The ClinicalTrials.gov registry entry for NCT00991133 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 44-participant average among 4 other Lymphoblastic Leukemia, Acute, Childhood trials with a reported enrollment target (82% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lymphoblastic Leukemia, Acute, Childhood appearing as the primary indexed condition, and to 1 intervention - of which Clofarabine incorporated into a 5-drug regimen is the first listed.
NCT00991133 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, Colorado, Georgia.
Frequently Asked Questions
What is clinical trial NCT00991133 about?
NCT00991133 is a clinical study titled "A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL)". 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).
What is the current status of trial NCT00991133?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2009-10. Estimated completion is 2011-04.
What conditions does trial NCT00991133 study?
This clinical trial studies the following conditions: Lymphoblastic Leukemia, Acute, Childhood.
What interventions are being tested in trial NCT00991133?
The interventions under investigation include: Clofarabine incorporated into a 5-drug regimen (DRUG).
Who is sponsoring clinical trial NCT00991133?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00991133 being conducted?
This trial has 6 study locations across California, Colorado, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.