Ignite Creation Date:
2024-05-06 @ 8:22 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02723435
Status:
WITHDRAWN
Last Update Posted:
2018-05-04
First Post:
2016-03-25
Brief Title:
Midostaurin in Treating Older Patients With Mutated Acute Myeloid Leukemia Post-Transplant
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
An Open-Label Extension Study of Post-Transplant Maintenance Midostaurin PKC412 in Elderly Patients Age 60 Years With FLT3-ITDTKD Mutated AML Who Previously Received Midostaurin and Decitabine as Part of Study HEMAML0022 CPKC412AUS27T
Status:
WITHDRAWN
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Logistical and administrative issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase 2 trial studies the side effects and how well midostaurin works in treating older patients with acute myeloid leukemia with change in genetic material post-hematopoietic cell transplantation Midostaruin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving midostaruin post-transplant may improve patient outcomes
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy and safety of maintenance midostaurin a fms related tyrosine kinase 3 FLT3 inhibitor for elderly patients with FLT3-internal tandem duplication ITDtyrosine kinase domain TKD mutated acute myeloid leukemia AML who were previously enrolled on study HEMAML0022CPKC412AUS27T and have then undergone allogeneic transplant
SECONDARY OBJECTIVES
I To determine whether maintenance midostaurin after allogeneic transplant decreases the relapse rate in patients with FLT3-ITDTKD mutated AML
OUTLINE
Beginning 30 days post-hematopoietic cell transplantation HCT patients receive midostaurin orally PO twice daily BID on days 1-28 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then up to 1 year
I To determine the efficacy and safety of maintenance midostaurin a fms related tyrosine kinase 3 FLT3 inhibitor for elderly patients with FLT3-internal tandem duplication ITDtyrosine kinase domain TKD mutated acute myeloid leukemia AML who were previously enrolled on study HEMAML0022CPKC412AUS27T and have then undergone allogeneic transplant
SECONDARY OBJECTIVES
I To determine whether maintenance midostaurin after allogeneic transplant decreases the relapse rate in patients with FLT3-ITDTKD mutated AML
OUTLINE
Beginning 30 days post-hematopoietic cell transplantation HCT patients receive midostaurin orally PO twice daily BID on days 1-28 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then up to 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| NCT02723435 | OTHER | Stanford University | None |
| NCI-2016-00424 | REGISTRY | None | None |
| HEMAML0022-EXT | OTHER | None | None |