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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2020

Interventions

  • Drug: PD1 antibody´╝îlenalidomide
    • PD-1 antibody, 2mg/kg,d1; Lenalidomide,10mg d1-14; 2 weeks is a course of treatment, altogether 6 courses of treatment.

Arms, Groups and Cohorts

  • Experimental: PD-1 antibody and lenalidomide
    • PD-1 antibody, 2mg/kg,d1; Lenalidomide,10mg d1-14; 2 weeks is a course of treatment, altogether 6 courses of treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Change of Epstein-Barr virus(EBV)-DNA before and after therapy
    • Time Frame: Change from before and 2, 4, 6,8,10 and 12 weeks after initiating PD1 antibody and lenalidomide therapy
  • Ultrasonic spleen thickness
    • Time Frame: Change from before and 2, 4, 6,8,10 and 12 weeks after initiating PD1 antibody and lenalidomide therapy
  • EBV lymphocyte subsets
    • Time Frame: Change from before and 2, 4, 6,8,10 and 12 weeks after initiating PD1 antibody and lenalidomide therapy

Secondary Measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    • Time Frame: through study completion, an average of 1 years
    • Adverse events including thyroid function´╝î liver function damage, myelosuppression, infection, bleeding and so on.
  • survival
    • Time Frame: from the time patients received PD1 antibody and lenalidomide therapy up to 12 months or September 2019

Participating in This Clinical Trial

Inclusion Criteria

1. Patients were older than 1 years of age.

2. According to the HLH-04 diagnostic criteria, it meets the HLH diagnostic criteria. EBV infection occurs in cells with EBV-DNA copy number significantly increased in peripheral blood or tissue, or where EBV coding small RNA(EBER) is detected in tissue or peripheral blood. Or Straus' 1988 diagnostic criteria for CAEBV.

3. EBV-HLH or CAEBV are in remission.

4. 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.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Friendship Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhao Wang, Doctor – Beijing Friendship Hospital
  • Overall Contact(s)
    • jingshi wang, 86-010-63139862, wangjingshi987@126.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.