Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-30 @ 3:49 PM
Study NCT ID:
NCT01064557
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2010-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"AIDA" Protocol (LAP 0493)
Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Organization:
Study Overview
Official Title:
Guideline for the Treatment of Newly Diagnosed Patients Eith Acutypromyelocytic Leukemia, Aged > 12 Months (1 Year) and <75 Years, Using All-trans Retinoic Acid in Combination With Idarubicin
Status:
UNKNOWN
Status Verified Date:
2020-10
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 main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: