Twice-per-weekSelinexor, 2 Days Melphalan

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06613035
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Sep 30, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen
    * Selinexor: 60 mg/day from days -9 to -5. * Melphalan: 60 mg/m² on days -8 and -7. * Intravenous Busulfan (Bu): 3.2 mg/kg on days -6 and -5. * Fludarabine (Flu): 30 mg/m² on days -4, -3, and -2.
  • Experimental: Patients in the BF group will receive the BU3FLU5 conditioning regimen
    * Intravenous Busulfan (Bu): 3.2 mg/kg on days -9, -8, and -7. * Fludarabine (Flu): 30 mg/m² on days -6, -5, -4, -3, and -2.

Primary Outcome Measure

1-year RFS [ Time Frame: 1-year ]

Central Contacts

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