Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315705
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2006-04-18
Brief Title:
A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 12 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None