Ignite Creation Date:
2024-05-05 @ 9:38 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00931138
Status:
COMPLETED
Last Update Posted:
2009-07-02
First Post:
2009-06-29
Brief Title:
Treatment of Acute Myeloid Leukemia AML in Adults 50 to 70 Years Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 2
Sponsor:
Acute Leukemia French Association
Organization:
Acute Leukemia French Association
Study Overview
Official Title:
Treatment of AML in Adults 50 to 70 Years Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801
Status:
COMPLETED
Status Verified Date:
1999-08
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:
ALFA 9801
Brief Summary:
Randomized comparison of standard induction treatment with daunorubicin for 3 days and Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years Study of maintenance treatment with IL2
Detailed Description:
Patients from 50 to 70 years with de novo AML were randomized to receive ARAC 200 mg m² d IV x 7 d with either DNR 80 mgm²dx3d arm 1 or IDA 12 mg m²d x 3 d arm 2 or 4 d arm 3 The pts received a failing course of remedial Mitoxantrone involving x 2 and j ARAC 1g m 2 x d x 4 days The pts in CR then received 2 courses of consolidation with according to initial randomization either DNR 80 mg m² IDA 12 mg sqm x 1 d 1st treatment or 2 d 2nd treatment and ARAC 1 gsm 2jx x 4 days The pts in CR were then randomized persistent IL2 5 million IU m² x 5 d month in SC for 12 months or no treatment
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