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

A Clinical Trial of Programmed Cell Death Protein 1(PD1) Antibody and Lenalidomide as a Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis or Chronic Active EBV Infection(CAEBV)

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.

Study Overview

• Status: Recruiting
• Conditions: EBV Infection
• Intervention / Treatment: Drug: PD1 antibody; Drug: lenalidomide

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: jingshi wang; Phone Number: 86-010-63139862; Email: wangjingshi987@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: jingshi wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD-1 antibody; PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles.	Drug: PD1 antibody; 2mg/kg ivgtt on day 1(age<18 years); 200mg ivgtt on day 1(age >=18 years).; Drug: lenalidomide; 5mg orally once a day（age<18years) ,day 1-14; 10mg orally once a day(age>=18years), day 1-14.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spleen size	ultrasonic spleen size	6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Adverse events including thyroid function， liver function damage, myelosuppression, infection, bleeding and so on.	through study completion, an average of 1 years
survival	from the date of inclusion to date of death, irrespective of cause Adverse Events	1 year

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: September 8, 2019
• First Submitted That Met QC Criteria: September 8, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; DNA Virus Infections; Tumor Virus Infections; Herpesviridae Infections; Infections; Epstein-Barr Virus Infections; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antibodies; Lenalidomide
• Other Study ID Numbers: PD-1 antibody-EBV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No