Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01477606
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2011-11-17
Brief Title:
Protocol in Acute Myeloid Leukemia With FLT3-ITD
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
Official Title:
Phase-II Study Evaluating Midostaurin in Induction Consolidation and Maintenance Therapy Also After Allogeneic Blood Stem Cell Transplantation in Patients With Newly Diagnosed Acute Myeloid Leukemia Exhibiting a FLT3 Internal Tandem Duplication
Status:
COMPLETED
Status Verified Date:
2020-06
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 phase II single-arm open-label multi-center study in adult patients with Acute Myeloid Leukemia AML and FLT3-ITD as defined in inclusionexclusion criteria
The primary efficacy object is to evaluate the impact of midostaurin given in combination with intensive induction consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival EFS in adult patients with AML exhibiting a FLT3-ITD
Sample size 440 patients
The treatment duration of an individual patient is between 18 and 24 months Duration of the study for an individual patient including treatment induction consolidation chemotherapy or allogeneic SCT maintenance and follow-up period Maximum 8 years
The primary efficacy object is to evaluate the impact of midostaurin given in combination with intensive induction consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival EFS in adult patients with AML exhibiting a FLT3-ITD
Sample size 440 patients
The treatment duration of an individual patient is between 18 and 24 months Duration of the study for an individual patient including treatment induction consolidation chemotherapy or allogeneic SCT maintenance and follow-up period Maximum 8 years
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-003168-63 | EUDRACT_NUMBER | None | None |