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

Capital Medical University

Status and phase: Unknown; Phase 3

Conditions: EBV Infection

Treatments: Drug: lenalidomide; Drug: PD1 antibody

Study type: Interventional

Funder types: Other

Identifiers

NCT04084626

PD-1 antibody-EBV

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

PD-1 antibody

Experimental group

Description:

PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles.

Treatment:

Drug: PD1 antibody

Drug: lenalidomide