The present study was a prospective one-arm clinical study, in which EBV-HLH/chronic active EBV infection patients were selected as the main subjects to evaluate the effect of PD-1 antibody and lenalidomide regimens on ebv-dna and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
2mg/kg ivgtt on day 1(age\<18 years); 200mg ivgtt on day 1(age \>=18 years).
5mg orally once a day(age\<18years) ,day 1-14; 10mg orally once a day(age\>=18years), day 1-14.
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGResponse rate
The rate of decline in EBV-DNA copy (defined as a 2log decrease in EBV-DNA copy) or negative rate in peripheral blood mononuclear cells and plasma
Time frame: 6 months
Spleen size
ultrasonic spleen size
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse events including thyroid function, liver function damage, myelosuppression, infection, bleeding and so on.
Time frame: through study completion, an average of 1 years
survival
from the date of inclusion to date of death, irrespective of cause Adverse Events
Time frame: 1 year
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