Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044889
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2002-09-06
Brief Title:
Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase II Open-Label Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 acute lymphoblastic leukemia ALL who have had at least 2 prior treatment regimens
This is a single arm open-label Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia AML Qualified patients must be refractory to one or two induction regimens or have relapsed one year from the date of confirmation of the initial complete remission CR There will be two phases in this study - an Induction phase and a Consolidation phase
This is a single arm open-label Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia AML Qualified patients must be refractory to one or two induction regimens or have relapsed one year from the date of confirmation of the initial complete remission CR There will be two phases in this study - an Induction phase and a Consolidation phase
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