NK/T-Cell Lymphoma
Conditions
Interventions
Epi-Immuno-Pe treatment group:Chidamide: 5 mg/tablet, oral, once daily, days 1-14
Decitabine: 20 mg/m^2 intravenous infusion, days 1-5
PD-1 inhibitor: 100 mg intravenous infusion, day 1
Pegaspargase: 2000 IU/m^2 intramuscular injection, day 6
one cycle every 21 days.
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed NK/T-cell lymphoma (according to the 2022 WHO diagnostic criteria). 2. Previously received at least one line of therapy (including radiotherapy and/or PD-1 inhibitors) and is assessed as having refractory or relapsed disease: failure to achieve at least Partial Response (PR) after =2 cycles of prior therapy, or disease progression after having achieved at least PR. 3. Age >60 years, OR deemed by the investigator as unsuitable for conventional chemotherapy due to poor performance status or comorbidities. 4. A whole-body PET/CT scan within 28 days prior to study enrollment must show at least one measurable lesion in two perpendicular dimensions (longest diameter of nodal lesion >15 mm, or longest diameter of extranodal lesion >10 mm). 5. ECOG score ranges from 0 to 3 points. 6. Clinical stage III or IV disease. 7. There is sufficient bone marrow and liver and kidney function, namely: absolute neutrophil count (ANC) >= 1000/µL, platelet count >= 50,000/µL, hemoglobin >= 80 g/dL; liver function: serum total bilirubin (TBIL) = 50 mL/min; heart function: heart function classification is below grade III (NYHA standard; echocardiography shows ejection fraction >= 50%); coagulation function: international normalized ratio (INR) 3 months. 9. Voluntarily participates in the clinical study: fully understands the study and provides signed informed consent; willing and able to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1. Suspected primary central nervous system lymphoma or secondary lymphoma involving the central nervous system. 2. Diagnosed with aggressive NK-cell leukemia or presence of hemophagocytic syndrome. 3. Presence of severe or uncontrolled autoimmune disease requiring other forms of immunosuppressive therapy; or active infection requiring systemic treatment; or active bleeding. 4. Presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may affect patient safety or compliance with study procedures, including but not limited to: poorly controlled cardiac symptoms or disease, such as: (1) NYHA class II or higher heart failure (2) Unstable angina (3) Myocardial infarction within the past year (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 5. Presence of a second primary tumor requiring ongoing treatment. 6. Contraindication or allergy to any drug in the combination regimen; or inability to swallow capsules, or presence of diseases significantly affecting gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction. 7. Patients infected with human immunodeficiency virus (HIV) and/or with acquired immunodeficiency syndrome. 8. Patients assessed as resistant to chidamide, pegaspargase, or PD-1 inhibitors. 9. Pregnant or lactating females, or reproductive-age patients unwilling to use contraception. 10. Other concurrent, uncontrolled medical conditions that the investigator believes may affect patient participation in the study; or any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may compromise subject safety, interfere with oral targeted drug absorption or metabolism, or expose the study outcome to excessive risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Overall Survival(OS);Safety endpoints: adverse events (AEs), serious adverse events (SAEs), drug-related adverse events, adverse events leading to premature study discontinuation, laboratory abnormalities, vital sign abnormalities, ECG abnormalities, clinical symptoms and signs abnormalities.;Patient-Reported Outcome-Based Quality of Life; | — |
Countries
China
Contacts
Public ContactHe Jingsong and Cai Zhen
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed