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

NCT06900088 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: IIT2024099
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence free survival rate (RFS)

  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)

  2 years

Secondary Outcomes (4)

• 2-year non-relapse mortality rate (NRM)

  2 years

• 2-year survival rate (OS)

  2 years

• Median overall survival (OS)

  2 years

• Cumulative incidence of acute graft-versus-host disease (GVHD)

  2 years

Study Arms (1)

patients with high-risk myeloid neoplasms after transplantation

EXPERIMENTAL

maintenance therapy with Selinexor combined with Azacitidine

Drug: Selinexor

Interventions

Selinexor DRUG

maintenance therapy with Selinexor combined with Azacitidine in patients with high-risk myeloid neoplasms after transplantation

patients with high-risk myeloid neoplasms after transplantation

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• with pre-transplant MRD-positive AML, i.e., patients who meet one of the following criteria:
• Age≥ 16 years old; any gender;
• High-risk MDS (IPSS-R or/and IPSS-M high-risk and above);
• 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
• Primary cases that have failed to respond to 2 courses of standard regimen chemotherapy;
• CR was followed by consolidation and intensive treatment with no recurrence within 12 months;
• It recurred 12 months later, but conventional chemotherapy was ineffective;
• or more relapses;
• 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:
• Proportion of abnormal myeloid cells \>0.01% by pre-transplant flow assay;
• 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.

You may not qualify if:

• Patients with any of the following are not eligible for enrollment in this study:
• Patients who relapsed within 3 months of transplantation or during maintenance therapy, including hematologic, molecular genetic, cytogenetic relapses, and extramedullary relapses.
• Known positive serology for HIV or active hepatitis B virus (HBV) and hepatitis C virus (HCV);
• Requirements for mental illness or other conditions that preclude cooperation with study treatment and monitoring;
• Patients who are pregnant or who are unable to use appropriate contraception during treatment;
• Suspected hypersensitivity to the experimental drug or any of its excipients;
• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

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

Tianjin, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic

Interventions

selinexor

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Erlie jiang

CONTACT

+86-15122538106; jiangerlie@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: March 28, 2025
• Study Start: April 25, 2025
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 28, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)