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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The experimental group | Experimental |
| |
| The control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab and lenalidomide | Drug | Drug: Sintilimab 200mg ivgtt on day 1. Drug: lenalidomide 10mg orally once a day, day 1-14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response 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 | Twelve weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Spleen size | Twelve weeks after treatment | |
| T and B lymphocyte subsets | Twelve weeks after treatment | |
| Pathological tissue or bone marrow |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jingshi wang | Contact | 86-010-63139862 | wangjingshi987@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Sintilimab placebo and lenalidomide placebo | Drug | Drug: Sintilimab placebo ivgtt on day 1. Drug: lenalidomide placebo orally once a day, day 1-14. |
|
| 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. | through study completion, an average of 1 years |
| survival | From enrollment until death or the end of the experiment | 1 year |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |