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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: Completed Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood, sponsored by Genzyme, a Sanofi Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00991133 record still lists
NCT00991133 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 44-participant average among 4 other Lymphoblastic Leukemia, Acute, Childhood trials with a reported enrollment target (82% lower).
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 lists 6 locations in 6 states (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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