Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151242
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2005-09-06
Brief Title:
Study on All-Trans Retinoic Acid Induction and Consolidation Therapy and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
Official Title:
Randomized Phase IIIII-Study on All-Trans Retinoic Acid in Combination With Induction and Consolidation Therapy as Well as Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2017-09
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 trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia AML
Detailed Description:
First Induction Therapy
Cytarabine 100 mgm² cont iv days 1-7
Idarubicin 12 mgm² iv days 135
Etoposide 100 mgm² iv days 1-3
ATRA 45 mgm² po days 6-8
ATRA 15 mgm² po days 9-21
Second Induction Therapy
Cytarabine 100 mgm² cont iv days 1-7
Idarubicin 12 mgm² iv days 1 and 3
Etoposide 100 mgm² iv days 1-3
ATRA 45 mgm² po days 6-8
ATRA 15 mgm² po days 9-21
Consolidation Therapy
cohort 1 ID 336
Cytarabine 3 gm² 2xdie iv Tag 135
ATRA 15 mgm² po Tag 6-21
Pegfilgrastim 6 mg sc day 10
cohort 2 ID 336
Cytarabine 3 gm² 2xdie iv Tag 123
ATRA 15 mgm² po Tag 4-21
Pegfilgrastim 6 mg sc day 8
Cytarabine 100 mgm² cont iv days 1-7
Idarubicin 12 mgm² iv days 135
Etoposide 100 mgm² iv days 1-3
ATRA 45 mgm² po days 6-8
ATRA 15 mgm² po days 9-21
Second Induction Therapy
Cytarabine 100 mgm² cont iv days 1-7
Idarubicin 12 mgm² iv days 1 and 3
Etoposide 100 mgm² iv days 1-3
ATRA 45 mgm² po days 6-8
ATRA 15 mgm² po days 9-21
Consolidation Therapy
cohort 1 ID 336
Cytarabine 3 gm² 2xdie iv Tag 135
ATRA 15 mgm² po Tag 6-21
Pegfilgrastim 6 mg sc day 10
cohort 2 ID 336
Cytarabine 3 gm² 2xdie iv Tag 123
ATRA 15 mgm² po Tag 4-21
Pegfilgrastim 6 mg sc day 8
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