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: Interventional
- Study Design
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 1, 2020
- 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
- Change of Epstein-Barr virus(EBV)-DNA
- Time Frame: 6 months
- PBMC and plasma EBV-DNA
- The 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.
- Time Frame: 1 year
- from the date of inclusion to date of death, irrespective of cause Adverse Events
Participating in This Clinical Trial
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
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
- 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, email@example.com
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