Clinical Study on Maintenance Therapy With Selinexor Combined With Azacitidine After Allogeneic Hematopoietic Stem Cell Transplantation for NK/T-cell Lymphoma

November 29, 2025 updated by: Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Allogeneic hematopoietic stem cell transplantation is an important treatment method for NK-T cell lymphoma, but the recurrence rate after transplantation is relatively high. Therefore, exploring efficient and low-toxicity maintenance treatment strategies after transplantation is a key challenge for improving prognosis. Previous studies have reported that selinexor and azacitidine show good anti-tumor activity in relapsed/refractory NKTCL. Thus, we conducted a single-center, single-arm, exploratory study on the efficacy and safety of selinexor combined with azacitidine as maintenance therapy after allogeneic hematopoietic stem cell transplantation for NK/T cell lymphoma, to evaluate the efficacy and safety of the combined regimen, with the aim of providing reference for clinical treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xianming Song, M.D
  • Phone Number: +86 189 1802 9692
  • Email: shongxm@139.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Age range: 18-70 years old, gender not restricted; 2. Diagnosed with NK/T-cell lymphoma (NKTCL) according to the 2022 WHO criteria; 3. Received allogeneic hematopoietic stem cell transplantation for NKTCL, with no restrictions on the type of donor; 4. Bone marrow chimerism is complete donor chimerism (T-cell chimerism > 95%); 5. ECOG: 0-1 points; 6. Blood routine must meet the following requirements: (1) ANC >= 1.0 × 10^9/L; (2) PLT >= 75 × 10^9/L; 7. The patient must be capable of understanding and willing to participate in this study, and sign the informed consent form.

Exclusion Criteria:

  • 1. Those who are known to be allergic to azacitidine or selinexor; 2. Those with active acute GVHD of grade 2 or above; 3. Those with moderate or severe chronic GVHD; 4. Any unstable systemic diseases: including but not limited to unstable angina pectoris, cerebrovascular accident or transient ischemic attack (within 3 months before screening), myocardial infarction (within 3 months before screening), congestive heart failure (NYHA classification >= grade III), severe arrhythmia requiring drug treatment after pacemaker implantation, liver, kidney or metabolic diseases; patients with pulmonary hypertension. 5. Those with active uncontrolled infections: with hemodynamic instability related to infection, or new symptoms or signs of infection worsening, or new infection lesions found on imaging, persistent fever without symptoms or signs that cannot be ruled out as infection; 6. HIV-infected individuals; 7. Patients with active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral treatment; 8. History of autoimmune diseases; 9. Pregnant or lactating women; 10. Those who are currently receiving other investigational drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group

For patients with NK/T-cell lymphoma, maintenance therapy with selinexor combined with azacitidine was initiated 60-90 days after allogeneic hematopoietic stem cell transplantation. The specific treatment regimen was as follows:

Selinexor 40 mg once a week; if the blood routine was intolerable (i.e., PLT ≤ 50×109/L), 20 mg once a week could be used. Azacitidine 16 mg/m2/d, days 1-5.

A 28-day treatment cycle was adopted, and the treatment was continued for 2 years.
Drug: Selinexor, azacitidine

For patients with NK/T-cell lymphoma, maintenance therapy with selinexor combined with azacitidine was initiated 60-90 days after allogeneic hematopoietic stem cell transplantation. The specific treatment regimen was as follows:

Selinexor 40 mg once a week; if the blood routine was intolerable (i.e., PLT ≤ 50×109/L), 20 mg once a week could be used. Azacitidine 16 mg/m2/d, days 1-5.

A 28-day treatment cycle was adopted, and the treatment was continued for 2 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: two years after transplantation
two years after transplantation
over-all survival
Time Frame: two years after transplantation
two years after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
cumulative recurrence rate
Time Frame: one year after transplantation
one year after transplantation
cumulative recurrence rate
Time Frame: two years after transplantation
two years after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2025

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

November 29, 2025

First Submitted That Met QC Criteria

November 29, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 29, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHSYXY-NKT-Seli-202505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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