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

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Friendship Hospital
• Treatments: Antibodies; Immunoglobulins; Lenalidomide

Criteria

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.