Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients

Phase 2

Not yet recruiting

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia
• Interventions: Drug: Selinexor

• Registration Number: NCT06900088
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

Efficacy and Safety of Selinexor Combined with Azacitidine as Maintenance Therapy in High-Risk Myeloid Neoplasms Patients Post-Transplantation: A Single-Center, Single-Arm, Exploratory Study

Detailed Description

Treatment period: From the time of transplantation, after screening by inclusion and exclusion criteria, patients who meet the criteria are enrolled and given maintenance therapy with Selinexor in combination with azacitidine (Selinexor: 40 mg/weekly, administered on D1; azacitidine: 50 mg/m2\*5d; every 28 days for a cycle of treatment, for at least one year of medication, or until progression of the disease, or until the development of intolerable toxicity, whichever comes first)

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Study Start: 2025-04-25
• Primary Completion: 2025-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with high-risk myeloid neoplasms after transplantation	Selinexor	maintenance therapy with Selinexor combined with Azacitidine

Primary Outcome Measures

Name	Time	Method
2-year recurrence free survival rate (RFS)	2 years	the rate at which a patient has been on the drug for at least 1 year without morphological relapse or death of the subject from the transplantation date (whichever comes first)

Secondary Outcome Measures

Name	Time	Method
2-year non-relapse mortality rate (NRM)	2 years	incidence of death from causes other than AML relapse/progression from the date of transplantation to the date of the subject's death
2-year survival rate (OS)	2 years	the 2-year survival rate from transplantation to death from any causes
Median overall survival (OS)	2 years	The time from transplantation to death from any causes
Cumulative incidence of acute graft-versus-host disease (GVHD)	2 years	Cumulative incidence of grade II-IV acute GVHD at 6 months after enrollment. Acute GVHD will be graded based on the diagnostic and severity scores used by the Blood and Bone Marrow Transplantation Clinical Trial Network (BMTCTN).

Trial Locations

Locations (1)

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.; 🇨🇳 Tianjin, China