Central Nervous System Lymphoma, Diffuse Large B Cell Lymphoma, Extranodal Extension, Relapse/Recurrence
Conditions
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.
Interventions
DRUGLow-Dose Decitabine plus anti-PD-1
Decitabine 10mg/d，VD d1-5; PD-1 200mg，d8
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 1-year | ORR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Benefit Rate | 1-year | The total percentage of subjects who achieved minimal response (MR) or above after treatment |
| Progression Free Survival | 1-year | The time interval between first treatment and first recorded progress disease, or death from any cause, the deadline is the date of the last examination |
| Duration of Remission | 1-year | The time interval from first recording to disease remission (PR and above criteria) to first recording to PD. For responding subjects with no documented disease progression, the deadline is the date of the last examination |
| Time to Response | 1-year | The time interval between subjects first receiving treatment and first recording of disease remission (PR and above) |
| Overall Survival | 1-year | The time interval between when the subject first received treatment and when death from any cause was recorded. For subjects whose death is not recorded, the deadline is the most recent point in time at which the subject is still alive |
Countries
China
Outcome results
None listed