Maintenance Therapy With Selinexor and Azacitidine in TP53 Mutant AML/MDS After Transplantation

Sponsor
Daihong Liu
Study ID
NCT07094464
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Allogeneic Hematopoietic Stem Cell Transplantation
  • TP53-mutated MDS and AML

Eligibility Criteria

Sex
ALL
Age
14 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Maintenance Therapy with Selinexor and Azacitidine — DRUG
    1. Selinexor: Oral administration in 4 cycles: \- Dose Escalation Phase: Cohort 1: Selinexor, 20 mg, twice a week for 2 weeks Cohort 2: Selinexor, 40 mg, twice a week for 2 weeks Cohort 3: Selinexor, 60 mg, twice a week for 2 weeks \- Dose Expansion: MTD/RP2D will be determined based on safety. 2. Azacitidine: 35 mg/m² for 5 days.

Study Details

This study aims to explore the safety and efficacy of selinexor combined with azacitidine for maintenance therapy in TP53 mutant AML/MDS patients following transplantation.

Key Dates

Start date
Jun 1, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Assigned Interventions
    1）Treatment will begin approximately 3 months post-transplant. The study duration will be 1 year with treatment cycles every 3 months, totaling 4 cycles. 1. Selinexor: Single-arm phase I study with sequential dose escalation of Selinexor. Three dose levels will be tested in separate cohorts: * Cohort 1: Selinexor, 20 mg, twice a week for 2 weeks * Cohort 2: Selinexor, 40 mg, twice a week for 2 weeks * Cohort 3: Selinexor, 60 mg, twice a week for 2 weeks 2. Azacitidine: 35 mg/m² for 5 days. 2）Bone marrow morphology, characteristic gene mutation or fusion gene quantification, immunophenotyping, chimerism, or transplant-related FISH will be assessed before and after each treatment cycle, according to the follow-up schedule post-transplant. Patients with hematological relapse at any time will discontinue from the experimental group and receive an alternative treatment.

Primary Outcome Measure

Disease relapse [ Time Frame: 1 year after transplantation ]

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