PD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Trial of Programmed Cell Death Protein 1(PD1) Antibody and Lenalidomide as a Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis or Chronic Active EBV Infection(CAEBV)

Conditions
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EBV Infection

Intervention / Treatment
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* Drug: PD1 antibody
* Drug: lenalidomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with CAEBV confirmed by 2016 Revised World Health Organization classification. If the patient has previously suffered CAEBV-HLH, the HLH should be in remission. A woman of childbearing age must be determined not to be pregnant by a pregnancy test and is willing to take effective measures to prevent pregnancy during the trial period and ≥12 months after the last administration of the drug; All male subjects used contraceptive methods during the study period and ≥6 months after the last administration; Ages Eligible for Study: 1 Year to 65 Years. Sign the informed consent. Exclusion Criteria: Heart function above grade II (NYHA). Pregnancy or lactating Women. Allergic to PD-1 antibody or lenalidomide. Active bleeding of the internal organs. uncontrollable infection. Participate in other clinical research at the same time.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD-1 antibody<br>PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles. | Drug: PD1 antibody<br>* 2mg/kg ivgtt on day 1(age<18 years); 200mg ivgtt on day 1(age >=18 years).<br>Drug: lenalidomide<br>* 5mg orally once a day（age<18years) ,day 1-14; 10mg orally once a day(age>=18years), day 1-14.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |