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NCT00315705 · ClinicalTrials.gov registry record · Phase 1
A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00315705 is a Phase 1 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 50 participants.
The verdict
NCT00315705, a Phase 1 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Cyclophosphamide
- DRUG Etoposide
- DRUG clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2006-03 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00315705
The ClinicalTrials.gov registry entry for NCT00315705 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT00315705 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00315705 about?
NCT00315705 is a clinical study titled "A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.". 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 resp...
What is the current status of trial NCT00315705?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2006-03. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00315705?
The interventions under investigation include: Cyclophosphamide (DRUG), Etoposide (DRUG), clofarabine (DRUG).
Who is sponsoring clinical trial NCT00315705?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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