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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	14 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05816746
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Chinese PLA General Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Diffuse Large B Cell Lymphoma, Relapse/Recurrence, Extranodal Extension, Central Nervous System Lymphoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Treatment group

Decitabine 10mg/d，VD d1-5; PD-1 200mg，d8

Interventions

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

Decitabine 10mg/d，VD d1-5; PD-1 200mg，d8

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

ChinaPLAGH, Beijing, Beijing, China

Status

Recruiting

Address

ChinaPLAGH

Beijing, Beijing, 100853

Site Contact

Yu Zhao, Graduate

[email protected]

010-66937232

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