Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07094464
PHASE1

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

Sponsor: Daihong Liu

View on ClinicalTrials.gov

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

DRUG

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