Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098033
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2004-12-02
Brief Title:
Investigation of Clofarabine in Acute Leukemias
Sponsor:
University of Texas
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias
Status:
COMPLETED
Status Verified Date:
2004-12
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:
The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia AML acute lymphocytic leukemia ALL and chronic myelogenous leukemia CML in accelerated and blastic phases
Detailed Description:
The specific aims of the project are 1 conduct the phase II study of clofarabine and evaluate the antileukemic efficacy in AML ALL and CML-accelerated and blastic phases in terms of complete response CR rate response duration and survival and 2 analyze the relationship between cellular uptake and retention of clofarabine triphosphate the active metabolite inhibition of DNA synthesis and clinical outcome
Completion date provided represents the completion date of the grant per OOPD records
Completion date provided represents the completion date of the grant per OOPD records
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