drugset / Trial / NCT07632170

The Efficacy and Safety of Selinisole Combined With Azacitidine and Venetoclax in the Treatment of Newly Diagnosed High-risk Myeloid Tumors With TP53 Mutations

NCT07632170

Not yet recruiting 30 enrolled Bing Han
NaSingle-groupOpen-labelTreatment

Summary

Patients with high-risk myeloid tumors accompanied by TP53 mutations have a poor survival prognosis, and there are still many unmet treatment needs. The current treatment regimens have many limitations. Selinisol, as a novel export protein inhibitor, has good anti-tumor activity. The current preclinical and preliminary clinical research results abroad suggest its effectiveness and safety. This study aims to evaluate the efficacy and safety of AZA combined with selinisole (with or without venetoclax) in the treatment of patients with high-risk myeloid tumors with TP53 mutations through a multicenter, prospective clinical study.

Timeline

Start
2026-11-01
Primary completion
2027-10-01
Completion
2027-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 100 mg/m2
Subject Selinexor Other / unclassified 60 mg
Subject Venetoclax Small molecule 100 mg

Indications