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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 antibody | Experimental | PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD1 antibody | Drug | 2mg/kg ivgtt on day 1(age<18 years); 200mg ivgtt on day 1(age >=18 years). |
|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Spleen size | ultrasonic spleen size | 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. |
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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 | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| lenalidomide | Drug | 5mg orally once a day(age<18years) ,day 1-14; 10mg orally once a day(age>=18years), day 1-14. |
|
| through study completion, an average of 1 years |
| survival | from the date of inclusion to date of death, irrespective of cause Adverse Events | 1 year |
| D014412 |
| Tumor Virus Infections |
| 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 |