UnknownPhase 3

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

China40 participantsStarted 2019-09-15

Plain-language 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.

Who can participate

Age range1 Year – 65 Years

SexALL

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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.

What they're measuring

Response rate

Timeframe: 6 months

Trial details

NCT IDNCT04084626

SponsorBeijing Friendship Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

Contact for this trial

jingshi wang

86-010-63139862 wangjingshi987@126.com

View on ClinicalTrials.gov More EBV Infection trials