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

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study ID
NCT07276698
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • NK T-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor, azacitidine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 30, 2025
Status verified
Nov 2025
Primary completion
Dec 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

progression-free survival [ Time Frame: two years after transplantation ]

Central Contacts