Treatment for relapsed diffuse large B cell lymphoma with Decitabine and anti-PD-1

Low-Dose Decitabine Plus Anti-PD-1 Treatment for Relapsed/Refractory Diffuse Large B Cell Lymphoma With Extranodal (Esp. Central Nervous System) Involvement: A PhaseⅡClinical Trial

This study is testing a new treatment combining Decitabine and anti-PD-1 therapy to see if it helps people with relapsed diffuse large B cell lymphoma, especially those with brain involvement.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 14 Years to 80 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05816746 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of a combination treatment using Low-Dose Decitabine and anti-PD-1 therapy for patients with relapsed or refractory diffuse large B cell lymphoma, particularly those with extranodal involvement in the central nervous system. The treatment regimen consists of cycles lasting three weeks, with a total duration of up to two years, or until disease progression or unacceptable toxicity occurs. Patients will be monitored for long-term outcomes following treatment completion.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 14-80 with pathologically confirmed relapsed/refractory diffuse large B cell lymphoma and central nervous system involvement.

Not a fit: Patients with autoimmune diseases requiring long-term immunosuppressive therapy or those with a history of other tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat lymphoma, potentially improving survival rates.

How similar studies have performed: While there have been studies exploring similar combinations of therapies, this specific approach is novel and has not been extensively tested.

Eligibility 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

Where this trial is running

Beijing, Beijing

• ChinaPLAGH — Beijing, Beijing, China (RECRUITING)

Conditions: Diffuse Large B Cell Lymphoma, Relapse/Recurrence, Extranodal Extension, Central Nervous System Lymphoma