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
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2022

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Response rate
    • Time Frame: 6 months
    • 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

Secondary Measures

  • Spleen size
    • Time Frame: 6 months
    • ultrasonic spleen size
  • 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, liver function damage, myelosuppression, infection, bleeding and so on.
  • survival
    • Time Frame: 1 year
    • from the date of inclusion to date of death, irrespective of cause Adverse Events

Participating in This Clinical Trial

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.

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, Principal Investigator – Beijing Friendship Hospital
  • Overall Contact(s)
    • jingshi wang, 86-010-63139862, wangjingshi987@126.com

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