PD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Response rate [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 Outcome Measures
- Spleen size [6 months]
ultrasonic spleen size
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [through study completion, an average of 1 years]
Adverse events including thyroid function， liver function damage, myelosuppression, infection, bleeding and so on.
- survival [1 year]
from the date of inclusion to date of death, irrespective of cause Adverse Events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with CAEBV confirmed by 2016 Revised World Health Organization classification.
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If the patient has previously suffered CAEBV-HLH, the HLH should be in remission.
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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;
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Ages Eligible for Study: 1 Year to 65 Years.
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Sign the informed consent.
Exclusion Criteria:
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Heart function above grade II (NYHA).
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Pregnancy or lactating Women.
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Allergic to PD-1 antibody or lenalidomide.
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Active bleeding of the internal organs.
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uncontrollable infection.
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Participate in other clinical research at the same time.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing | China | 100050 |
Sponsors and Collaborators
- Beijing Friendship Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PD-1 antibody-EBV