Decitabine and Anti-PD-1 in R/R DLBCL

• Status: Recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Decitabine

Criteria

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