Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06900088

Not yet recruiting

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

Interventional

Phase 2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Last Updated: March 28, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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

Show Detailed Description

Treatment Category

Other Drugs

Required Mutations

MET

Trial Started

April 25, 2025

Last Updated by Sponsor

March 28, 2025

Estimated Completion

October 30, 2025

Contact Study

Name:Erlie jiang

Email:jiangerlie@ihcams.ac.cn

Phone:+86-15122538106

Eligibility

Inclusion Criteria

with pre-transplant MRD-positive AML, i.e., patients who meet one of the following criteria:

1. Age≥ 16 years old; any gender;

2. High-risk MDS (IPSS-R or/and IPSS-M high-risk and above);

3. High relapse risk AML, including relapsed refractory AML and patients with pre-transplant MRD-positive AML, i.e., patients who meet one of the following criteria:

(1)Refractory AML is defined as meeting one of the following conditions

1. Primary cases that have failed to respond to 2 courses of standard regimen chemotherapy;

2. CR was followed by consolidation and intensive treatment with no recurrence within 12 months;

3. It recurred 12 months later, but conventional chemotherapy was ineffective;

4. 2 or more relapses;

5. Extramedullary leukemia persists. (2)Relapsed AML i.e., re-initialization of leukemic cells in the peripheral blood after complete remission (CR) or bone marrow primitive cells >0.050 (except for other reasons such as bone marrow reconstitution after consolidation chemotherapy) or extramedullary infiltration of leukemic cells.

(3)Positive pre-transplant MRD, i.e., one of the following conditions is met:

1. Proportion of abnormal myeloid cells >0.01% by pre-transplant flow assay;

2. Positive pre-transplantation molecular biology-related tests. (4)AML with poor prognosis (according to the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Myeloid Leukemia (Non-Acute Promyelocytic Leukemia) 2023 Edition) 4.Meets WHO diagnostic criteria for staging CMML; 5.MDS or CMML transforms AML.

Exclusion Criteria

Patients with any of the following are not eligible for enrollment in this study:

1. Patients who relapsed within 3 months of transplantation or during maintenance therapy, including hematologic, molecular genetic, cytogenetic relapses, and extramedullary relapses.

2. Known positive serology for HIV or active hepatitis B virus (HBV) and hepatitis C virus (HCV);

3. Requirements for mental illness or other conditions that preclude cooperation with study treatment and monitoring;

4. Patients who are pregnant or who are unable to use appropriate contraception during treatment;

5. Suspected hypersensitivity to the experimental drug or any of its excipients;

6. Active heart disease, defined as one or more of the following:

（1）History of uncontrolled or symptomatic angina; （2）Myocardial infarction less than 6 months from study entry; （3）History of tardive dyskinesia requiring medication or clinically significant symptoms; （4）Uncontrolled or symptomatic congestive heart failure (> NYHA class 2) （5）Ejection fraction is below the lower limit of the normal range. 7. Those deemed unsuitable for enrollment by the investigator.

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll20

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: maintenance therapy with Selinexor combined with Azacitidine

Interventions:

Selinexor

Outcome Measures

Primary Outcome Measures

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

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).

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Trial Sites

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

Tianjin, CN

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