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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04084626
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Zhao Wang, Beijing Friendship Hospital

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.

Condition or disease Intervention/treatment Phase
EBV Infection Drug: PD1 antibody Drug: lenalidomide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change of Epstein-Barr virus(EBV)-DNA [ Time Frame: 6 months ]
    PBMC and plasma EBV-DNA

  2. The spleen size [ Time Frame: 6 months ]
    Ultrasonic spleen size


Secondary Outcome Measures :
  1. 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.

  2. survival [ Time Frame: 1 year ]
    from the date of inclusion to date of death, irrespective of cause Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084626


Contacts
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Contact: jingshi wang 86-010-63139862 wangjingshi987@126.com

Locations
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China, Beijing
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: jingshi wang         
Sponsors and Collaborators
Beijing Friendship Hospital

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Responsible Party: Zhao Wang, Principal Investigator, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT04084626    
Other Study ID Numbers: PD-1 antibody-EBV
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lenalidomide
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents