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Trial Title:
Decitabine and Anti-PD-1 in R/R DLBCL
NCT ID:
NCT05816746
Condition:
Diffuse Large B Cell Lymphoma
Relapse/Recurrence
Extranodal Extension
Central Nervous System Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Extranodal Extension
Recurrence
Decitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Low-Dose Decitabine plus anti-PD-1
Description:
Decitabine 10mg/d，VD d1-5; PD-1 200mg，d8
Arm group label:
Treatment group
Other name:
DP
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.
Criteria for 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
Gender:
All
Minimum age:
14 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
ChinaPLAGH
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Zhao, Graduate
Phone:
010-66937232
Email:
zhaoyu301@126.com
Contact backup:
Last name:
Sai Huang, Graduate
Phone:
010-66937232
Email:
helinahs@qq.com
Investigator:
Last name:
Yu Zhao, Graduate
Email:
Principal Investigator
Investigator:
Last name:
Sai Huang, Graduate
Email:
Principal Investigator
Start date:
May 15, 2023
Completion date:
March 1, 2026
Lead sponsor:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05816746
