Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613035
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
Twice-per-weekSelinexor 2 Days Melphalan
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Twice-per-week Selinexor 2 Days Melphalan Plus BU2FLU3 Compared with BU3FLU5 for Elder High-risk Acute Myeloid Leukemia Undergoing Allogenic Hematopoietic Cell Transplantation a Multi-center Randomized Phase 3 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Twice-per-week Selinexor 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation a multi-center randomized phase 3 trial
Detailed Description:
Twice-per-week Selinexor 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation a multi-center randomized phase 3 trial Primary Objective The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT
Secondary Objective The secondary objective of this study is to compare leukemia relapse engraftment GVHD OS TRM AEs and RRT between Sel2Mel2BU2FLU3 and BU3FLU5 groups
Secondary Objective The secondary objective of this study is to compare leukemia relapse engraftment GVHD OS TRM AEs and RRT between Sel2Mel2BU2FLU3 and BU3FLU5 groups
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