Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643195
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
Immediate Allogeneic Hematopoietic Stem
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Re-treatment for Patients with High Relapse Risk Acute Myeloid Leukemia a Randomised Open-label Phase 2 Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate whether immediate HSCT for patients with high-risk AML and intermediate-risk AML who have not achieved complete remission CR after their first induction therapy is non-inferior to re-treatment with chemotherapy
Detailed Description:
Stratification based on AML risk levels and induction treatment regimens
1 Disease control group patients proceeded to allogeneic HSCT as soon as possible
2 Retreatment group Receive a second course of anti-leukemic treatment prior to allogeneic HSCT The anti-leukemic treatment regimen will be determined based on the genetic mutation status Patients without targetable mutations will receive a combination of BCL-2 inhibitors and demethylating agents as salvage chemotherapy Patients with targetable mutations will receive appropriate targeted therapy eg FLT3 inhibitors IDH inhibitors
For patients who have already received targeted therapy during induction treatment the researchers may choose the treatment regimen based on the individual patients condition
1 Disease control group patients proceeded to allogeneic HSCT as soon as possible
2 Retreatment group Receive a second course of anti-leukemic treatment prior to allogeneic HSCT The anti-leukemic treatment regimen will be determined based on the genetic mutation status Patients without targetable mutations will receive a combination of BCL-2 inhibitors and demethylating agents as salvage chemotherapy Patients with targetable mutations will receive appropriate targeted therapy eg FLT3 inhibitors IDH inhibitors
For patients who have already received targeted therapy during induction treatment the researchers may choose the treatment regimen based on the individual patients condition
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