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Maintenance Therapy With Selinexor and Azacitidine in TP53 Mutant AML/MDS After Transplantation
Sponsor: Daihong Liu
Summary
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.
Official title: A Single-Arm, Open-Label Phase I Clinical Study of Selinexor Combined With Azacitidine for Maintenance Therapy in TP53 Mutant AML/MDS Patients Post-Transplant
Key Details
Gender
All
Age Range
14 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-06-01
Completion Date
2028-12-30
Last Updated
2025-07-30
Healthy Volunteers
No
Interventions
Maintenance Therapy with Selinexor and Azacitidine
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.
Locations (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China