Overview
Patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial.
Description
To evaluate the effectiveness and safety of patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial. Enrollment was planned to be completed within 2 years, and all trials were followed up for 12 months after the last enrolled patient completed treatment. All cases will be followed up and the long-term curative effect will be observed and recorded.
Eligibility
Inclusion Criteria:
- 14-80 years old, male or female;
- Pathologically confirmed relapsed/refractory diffuse large B cell lymphoma with extranodal (central nervous system) involvement;
- Expected survival of more than 3 months;
- AST and ALT ≤ 3.0 ULN; TBIL and CCr ≤ 1.0 ULN;
- Inactive infection and severe mental illness
- ECOG score 0~2
- According to the New York Heart Association (NYHA) cardiac function grading standards, the heart function grading should be grade I or Grade II; Cardiac ejection fraction >50% or not lower than the lower limit of the range of laboratory test values at the study center; No pathological abnormality was found in ECG; There was no clinically significant pericardial effusion or pleural effusion
- The serum pregnancy test of female subjects must be negative
- Signed informed consent
Exclusion Criteria:
- Subjects with any autoimmune disease requiring long-term use of corticosteroids or immunosuppressive drugs or with a history of other tumors;
- Severe uncontrolled medical disease or active infection (including HIV+);
- Active gastrointestinal bleeding or 1 month history of gastrointestinal bleeding;
- Received allogeneic hematopoietic stem cell transplantation within 6 months or are participating in other clinical studies;
- Pregnant or nursing women;
- Subjects who must be forcibly detained for the treatment of mental or physical diseases (e.g. infectious diseases);
- The researcher thinks it is not suitable for this clinical study (such as poor compliance, drug abuse, etc.)
- The situation that the researcher judged was not suitable for inclusion