Back to resultsPD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV
Primary Purpose
EBV Infection
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
PD1 antibody
lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for EBV Infection
Eligibility Criteria
Inclusion Criteria:
- Patients with CAEBV confirmed by 2016 Revised World Health Organization classification.
- If the patient has previously suffered CAEBV-HLH, the HLH should be in remission.
- 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;
- Ages Eligible for Study: 1 Year to 65 Years.
- Sign the informed consent.
Exclusion Criteria:
- Heart function above grade II (NYHA).
- Pregnancy or lactating Women.
- Allergic to PD-1 antibody or lenalidomide.
- Active bleeding of the internal organs.
- uncontrollable infection.
- Participate in other clinical research at the same time.
Sites / Locations
- Beijing Friendship Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PD-1 antibody
Arm Description
PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Spleen size
ultrasonic spleen size
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.
survival
from the date of inclusion to date of death, irrespective of cause Adverse Events
Full Information
NCT ID
NCT04084626
First Posted
September 8, 2019
Last Updated
January 4, 2022
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04084626
Brief Title
PD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EBV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PD-1 antibody
Arm Type
Experimental
Arm Description
PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
PD1 antibody
Intervention Description
2mg/kg ivgtt on day 1(age<18 years); 200mg ivgtt on day 1(age >=18 years).
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Intervention Description
5mg orally once a day（age<18years) ,day 1-14; 10mg orally once a day(age>=18years), day 1-14.
Primary Outcome Measure Information:
Title
Response rate
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Spleen size
Description
ultrasonic spleen size
Time Frame
6 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Adverse events including thyroid function， liver function damage, myelosuppression, infection, bleeding and so on.
Time Frame
through study completion, an average of 1 years
Title
survival
Description
from the date of inclusion to date of death, irrespective of cause Adverse Events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with CAEBV confirmed by 2016 Revised World Health Organization classification.
If the patient has previously suffered CAEBV-HLH, the HLH should be in remission.
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;
Ages Eligible for Study: 1 Year to 65 Years.
Sign the informed consent.
Exclusion Criteria:
Heart function above grade II (NYHA).
Pregnancy or lactating Women.
Allergic to PD-1 antibody or lenalidomide.
Active bleeding of the internal organs.
uncontrollable infection.
Participate in other clinical research at the same time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jingshi wang
Phone
86-010-63139862
Email
wangjingshi987@126.com
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jingshi wang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV
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