NK / T cell lymphoma
Conditions
Interventions
PD1 antibody: PD1 antibody
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) According to the World Health Organization (who) classification of diseases in 2016, NK/T-cell lymphoma, nasal type, is diagnosed pathologically / cytologically; 2) The subjects must be NK / T-cell lymphoma patients with positive or continuously elevated EBV DNA level in plama after 4 courses of DDGP or P-GMox regimen; 3) The estimated survival time is more than 3 months; 4) The age range is 18-70 years old; 5) ECOG 15mm or extranodal lesions > 10mm) or FDG-PET positive lesions]; 7) All screening period laboratory tests are to be carried out in accordance with the protocol and should be performed within 14 days prior to enrollment. The values of laboratory tests performed by screening must meet the following criteria: Blood routine examination (no blood transfusion, no use of G-CSF, no drug correction within 14 days before screening): routine blood test (no blood transfusion, no use of G-CSF, no drug correction) was performed. a) Hb >= 80g/L b) ANC >= 1.0 x 10^9/L c) PLT >= 75 x 10^9/L Biochemical examination: a) TBIL = 50 ml / min (Cockcroft-Gault formula) Coagulation function (unless the subject is receiving anticoagulant therapy and coagulation parameters (Pt / INR and APTT) are within the expected range for anticoagulant therapy at the time of screening): international normalized ratio (INR) <= 1.5 x ULN; activated partial thromboplastin time (APTT) <= 1.5 x ULN; 8) The woman is not in lactation and is not pregnant and agree not to conceive during the study period and for 12 months thereafter. Male patients agree that their spouses would not be pregnant during the study period and for 12 months thereafter; 9) Sign the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1) Hemophagocytic syndrome is found; 2) Uncontrolled severe active infections, including active tuberculosis; 3) Central nervous system (CNS) lymphoma is known; 4) Patient has received allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 5) Autologous hematopoietic stem cell transplantation was performed within 6 months before treatment; 6) Pulmonary dysfunction; 7) Patients with autoimmune diseases (excluding autoimmune abnormalities associated with angioimmunoblastic lymphoma), hyperthyroidism or hypothyroidism; 8) Major surgery was performed within 28 days before treatment; 9) Live vaccine (except attenuated influenza vaccine) was given within 28 days before treatment; 10) Patients who are participating in other clinical studies, or planning to start this study less than 4 weeks before the end of the previous clinical study; 11) Severe medical diseases, such as organic heart disease, clinical symptoms or cardiac dysfunction (NYHA >= 2), history of myocardial infarction within 6 months before screening, ejection fraction < 50% by echocardiography, and severe thromboembolic disease; 12) HIV positive, syphilis antibody, HCV nucleic acid test positive; 13) Pregnant and lactating women; 14) In the past five years, patients suffered from other malignant tumors, except basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of cervix, carcinoma in situ of breast and carcinoma of gastrointestinal mucosa after radical treatment; 15) Other systemic anti-tumor therapy may be accepted during the study period; 16) Other psychological conditions that prevent patients from participating in the study or signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EBV DNA level in plama; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficiency; | — |
Countries
China
Contacts
Public ContactYuan Xiaoli
Henan Provincial People's Hospital
Outcome results
None listed