Viewing Study NCT00373529



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Last Modification Date: 2024-10-26 @ 9:27 AM
Study NCT ID: NCT00373529
Status: COMPLETED
Last Update Posted: 2014-04-14
First Post: 2006-09-07

Brief Title: A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia AML CLASSIC II
Sponsor: Genzyme a Sanofi Company
Organization: Sanofi

Study Overview

Official Title: A Phase II Study of Single Agent Clofarabine in Previously Untreated Older Adult Patients With Acute Myelogenous Leukemia AML for Whom Standard Induction Chemotherapy is Unlikely to be of Benefit
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: Clolar 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 study will evaluate the efficacy of clofarabine in elderly patients with acute myelogenous leukemia AML who are unlikely to benefit from treatment with intensive chemotherapy regimens cytarabine and anthracycline based regimens used in younger patients with AML
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