NCT06613035

Twice-per-weekSelinexor, 2 Days Melphalan

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Selinexor	Selinexor: 60 mg/day from days -9 to -5.
DRUG	Melphalan	Selinexor: 60 mg/day from days -9 to -5.
DRUG	Intravenous Busulfan	3.2 mg/kg on days
DRUG	Fludarabine	30 mg/m² on days

Timeline

• Start date: 2024-09-30
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2024-09-25
• Last updated: 2024-09-25

Locations

4 sites across 1 country: China