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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Decitabine 10mg/d,VD d1-5; PD-1 200mg,d8
ChinaPLAGH
Beijing, Beijing Municipality, China
RECRUITINGObjective Response Rate
ORR
Time frame: 1-year
Clinical Benefit Rate
The total percentage of subjects who achieved minimal response (MR) or above after treatment
Time frame: 1-year
Progression Free Survival
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
Time frame: 1-year
Duration of Remission
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 frame: 1-year
Time to Response
The time interval between subjects first receiving treatment and first recording of disease remission (PR and above)
Time frame: 1-year
Overall Survival
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
Time frame: 1-year
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