NK/T-cell lymphoma
Conditions
Interventions
Treatment group:For patients with NK/T-cell lymphoma who undergo allogeneic hematopoietic stem cell transplantation, selinexor combined with azacitidine maintenance therapy is initiated 60-90 days aft
if the blood routine is intolerable (i.e., PLT = 50×109/L), 20 mg once a week is allowed.
Azacitidine 16 mg/m2/d, days 1-5
A 28-day treatment cycle is adopted, and the treatment lasts for 2 years.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two years of progression-free survival rate after transplantation;Two years of over-all survival rate after transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The cumulative recurrence rate one year after transplantation;The cumulative recurrence rate two years after transplantation; | — |
Countries
China
Contacts
Public ContactSong Xianmin
Shanghai General Hospital
Outcome results
None listed