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A Single-Arm, Open Phase I Clinical Study of Selinexor in Combination With Azacitidine for the Treatment of High-Risk AML/MDS Patients After Allo-HSCT

NCT07779031 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-08-21

No results posted yet for this study

Summary

To explore the safety and efficacy of selinexor combined with azacitidine as post-transplant maintenance therapy for TP53-mutated AML/MDS.

Conditions

  • Acute Myeloid Leukaemia (AML)
  • MDS (Myelodysplastic Syndrome)

Interventions

DRUG

Azacitidine (AZA) Days 1 - 5

azacitidine 35mg/m2

DRUG

Selinexor

selinexor 20mg q2w

Sponsors & Collaborators

  • Liping Dou

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2028-04-30
Completion
2028-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07779031 on ClinicalTrials.gov