EBV Infection
Conditions
Brief summary
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.
Interventions
DRUGPD1 antibody
2mg/kg ivgtt on day 1(age\<18 years); 200mg ivgtt on day 1(age \>=18 years).
DRUGlenalidomide
5mg orally once a day（age\<18years) ,day 1-14; 10mg orally once a day(age\>=18years), day 1-14.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with CAEBV confirmed by 2016 Revised World Health Organization classification. 2. If the patient has previously suffered CAEBV-HLH, the HLH should be in remission. 3. 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; 4. Ages Eligible for Study: 1 Year to 65 Years. 5. Sign the informed consent.
Exclusion criteria
1. Heart function above grade II (NYHA). 2. Pregnancy or lactating Women. 3. Allergic to PD-1 antibody or lenalidomide. 4. Active bleeding of the internal organs. 5. uncontrollable infection. 6. Participate in other clinical research at the same time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spleen size | 6 months | ultrasonic spleen size |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | through study completion, an average of 1 years | Adverse events including thyroid function， liver function damage, myelosuppression, infection, bleeding and so on. |
| survival | 1 year | from the date of inclusion to date of death, irrespective of cause Adverse Events |
Countries
China
Contacts
Primary Contactjingshi wang
Outcome results
None listed