Ignite Creation Date:
2024-05-06 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03686345
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2018-07-04
Brief Title:
Midostaurin Associated With Standard Chemotherapy in Patients With Core-binding Factor Leukemia
Sponsor:
Niguarda Hospital
Organization:
Niguarda Hospital
Study Overview
Official Title:
Prospective Evaluation of a Continuation Therapy With Midostaurin in Adult Patients With Core-binding Factor Leukemia and Integrated Genetic Analysis a Multi-center Phase II Study
Status:
RECRUITING
Status Verified Date:
2023-11
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:
AML FLT3
Brief Summary:
The purpose of this single-arm open label phase-II trial is to determine whether the association of Midostaurin to standard induction consolidation therapy and in maintenance therapy as single agent is effective in decrease relapse incidence in patients with CBF-AML The single-arm open label phase-II study is based on data obtained from previous clinical and pre-clinical studies obtained by use of Midostaurin in patients with Acute Myeloid Leukemia with or without FLT3 mutations and in patients with Mast cell disorders characterized by mutations in the C-KIT gene The investigators believe that Midostaurin associated with standard therapy AnthracyclineAraC Induction to the consolidation regimen with high doses of araC and maintenance therapy to single agent in patients with acute myeloid leukemia core-binding factor can significantly reduce the incidence of recurrence of the disease occurring in 40-50 of cases treated with standard therapy
Detailed Description:
In this prospective Interventional Single-Arm Open-Label Phase-II Trial aims at demonstrating a decrease in the 2-year Relapse Incidence RI and in the 2-year Cumulative Relapse Incidence among the Midostaurin-treated patients compared to a cohort of historical controls The investigators established that a 20 net reduction in the 2-year RI may be a clinically significant goal So the investigators set our RI objective at 28 Furthermore the investigators will assess if the experimental treatment may obtain an increased 5-years Overall Disease-Free and Event free Survival The safety profile of Midostaurin given in combination with induction and consolidation chemotherapy and as a single agent in maintenance in CBFL patients will also be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-002094-18 | EUDRACT_NUMBER | None | None |