Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151255
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2005-09-06
Brief Title:
All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
Official Title:
Phase III - Study on All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2017-04
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:
This is a study looking at all-trans retinoic acid in combination with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia AML
Detailed Description:
First Induction Therapy
Cytarabine 100 mgm² cont iv days 1-5
Idarubicin 12 mgm² iv days 1 3
ATRA 45 mgm² po days 4-6 ATRA 15 mgm² po days 7-28
Second Induction Therapy
Cytarabine 100 mgm² cont iv days 1-5
Idarubicin 12 mgm² iv days 1 3
ATRA 45 mgm² po days 4-6 ATRA 15 mgm² po days 7-28
First Consolidation Therapy
Cytarabine 1000 mgm² bid iv days 1-3
Mitoxantrone 10 mgm² iv days 2 3
ATRA 15 mgm² po days 4-28
Second Consolidation Therapy
Etoposide 100 mgm² iv days 1-5
Idarubicin 12 mgm² iv days 13
ATRA 15 mgm² po days 4-28
Cytarabine 100 mgm² cont iv days 1-5
Idarubicin 12 mgm² iv days 1 3
ATRA 45 mgm² po days 4-6 ATRA 15 mgm² po days 7-28
Second Induction Therapy
Cytarabine 100 mgm² cont iv days 1-5
Idarubicin 12 mgm² iv days 1 3
ATRA 45 mgm² po days 4-6 ATRA 15 mgm² po days 7-28
First Consolidation Therapy
Cytarabine 1000 mgm² bid iv days 1-3
Mitoxantrone 10 mgm² iv days 2 3
ATRA 15 mgm² po days 4-28
Second Consolidation Therapy
Etoposide 100 mgm² iv days 1-5
Idarubicin 12 mgm² iv days 13
ATRA 15 mgm² po days 4-28
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