Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126321
Status:
UNKNOWN
Last Update Posted:
2010-02-02
First Post:
2005-08-02
Brief Title:
Cladribine Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia AML
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Phase II Study of Cladribine High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia
Status:
UNKNOWN
Status Verified Date:
2010-02
Last Known Status:
RECRUITING
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:
The purpose of this study is to evaluate the safety and the efficacy of cladribine high-dose cytarabine and idarubicin in the treatment of patients with relapsed acute myeloid leukemia
Detailed Description:
Considerable progress has been made in the induction therapy of acute myeloid leukemia AML however current therapeutic results are still unsatisfactory in those with relapsed disease The purine nucleoside analogue cladribine 2-chlorodeoxyadenosine 2-CdA has been shown to be a safe and active agent in acute myeloid leukemia Synergistic interaction between cladribine and cytarabine has been demonstrated in preclinical and clinical studies
The current multicenter phase II study was initiated to evaluate the efficacy and toxicity of cladribine high-dose cytarabine and idarubicin in the treatment of patients with relapsed AML Adult patients of all age groups can be enrolled in the trial but elderly patients will be treated with a less dose-intensive regimen
The current multicenter phase II study was initiated to evaluate the efficacy and toxicity of cladribine high-dose cytarabine and idarubicin in the treatment of patients with relapsed AML Adult patients of all age groups can be enrolled in the trial but elderly patients will be treated with a less dose-intensive regimen
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