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

NCT04084626 | Unknown Phase 3

• 1 other identifier: PD-1 antibody-EBV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Response rate

  The rate of decline in EBV-DNA copy (defined as a 2log decrease in EBV-DNA copy) or negative rate in peripheral blood mononuclear cells and plasma

  6 months

Secondary Outcomes (3)

• Spleen size

  6 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  through study completion, an average of 1 years

• survival

  1 year

Study Arms (1)

PD-1 antibody

EXPERIMENTAL

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

Drug: PD1 antibody; Drug: lenalidomide

Interventions

PD1 antibody DRUG

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

PD-1 antibody

lenalidomide DRUG

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

PD-1 antibody

Eligibility Criteria

• Age: 1 Year - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Epstein-Barr Virus Infections

Interventions

spartalizumab; Lenalidomide

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

jingshi wang

CONTACT

86-010-63139862; wangjingshi987@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: September 10, 2019
• Study Start: September 15, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 5, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)