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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Objective Response Rate
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment group
Decitabine 10mg/d，VD d1-5; PD-1 200mg，d8
Intervention: Low-Dose Decitabine plus anti-PD-1 (Drug)
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: 1-year
ORR
Secondary Outcomes
- Clinical Benefit Rate(1-year)
- Time to Response(1-year)
- Progression Free Survival(1-year)
- Duration of Remission(1-year)
- Overall Survival(1-year)
Investigators
Yu Zhao
Chief physician
Chinese PLA General Hospital