Status:
UNKNOWN
PD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
EBV Infection
Eligibility:
All Genders
1-65 years
Phase:
PHASE3
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 lenali...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04084626
Start Date
September 15 2019
End Date
July 1 2022
Last Update
January 5 2022
Active Locations (1)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050