This study is a multi-center, prospective, randomized, controlled clinical study to evaluate the effectiveness of a combination regimen of Sintilimab and lenalidomide in patients with chronic active EBV infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
51
Drug: Sintilimab 200mg ivgtt on day 1. Drug: lenalidomide 10mg orally once a day, day 1-14.
Drug: Sintilimab placebo ivgtt on day 1. Drug: lenalidomide placebo orally once a day, day 1-14.
Beijing Friendship Hospital, Capital Medical University
Beijing, 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: Twelve weeks after treatment
Spleen size
Time frame: Twelve weeks after treatment
T and B lymphocyte subsets
Time frame: Twelve weeks after treatment
Pathological tissue or bone marrow
Time frame: Twelve weeks after treatment
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 enrollment until death or the end of the experiment
Time frame: 1 year
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