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

NCT ID: NCT04084626

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-15
• Study Completion Date: 2022-07-01

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.

Conditions

EBV Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 antibody

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

Group Type: EXPERIMENTAL

PD1 antibody

Intervention Type: DRUG

2mg/kg ivgtt on day 1(age\<18 years); 200mg ivgtt on day 1(age \>=18 years).

lenalidomide

Intervention Type: DRUG

5mg orally once a day（age\<18years) ,day 1-14; 10mg orally once a day(age\>=18years), day 1-14.

Interventions

PD1 antibody

2mg/kg ivgtt on day 1(age\<18 years); 200mg ivgtt on day 1(age \>=18 years).

Intervention Type: DRUG

lenalidomide

5mg orally once a day（age\<18years) ,day 1-14; 10mg orally once a day(age\>=18years), day 1-14.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

jingshi wang

Role: CONTACT

wangjingshi987@126.com

86-010-63139862

Facility Contacts

jingshi wang

Role: primary

Other Identifiers

PD-1 antibody-EBV

Identifier Type: -

Identifier Source: org_study_id