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

Chinese PLA General Hospital (301 Hospital)

Status and phase

Enrolling

Phase 2

Conditions

Central Nervous System Lymphoma

Extranodal Extension

Diffuse Large B Cell Lymphoma

Relapse/Recurrence

Treatments

Drug: Low-Dose Decitabine plus anti-PD-1

Study type

Interventional

Funder types

Other

Identifiers

NCT05816746

DP in R/R DLBCL-P01

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

14 to 80 years old

Volunteers

No Healthy Volunteers

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