Programmed Cell Death Protein-1 (PD-1) Monoclonal Antibody for EBV-HLH and CAEBV as First-line Th… (NCT05039580) | Clinical Trial Compass
UnknownPhase 4
Programmed Cell Death Protein-1 (PD-1) Monoclonal Antibody for EBV-HLH and CAEBV as First-line Therapy
China36 participantsStarted 2021-05-15
Plain-language summary
EBV-HLH and CAEBV are both caused by EBV infection, part of them can rapidly lead to a syndrome of severe, life-threatening hyper-inflammation, with poor prognosis. Currently, the most effective treatment remains unknown. This study is trying to evaluate the efficacy and safety of PD-1 monoclonal antibody as a first-line therapy for EBV-HLH and CAEBV.
Who can participate
Age range12 Years – 70 Years
SexALL
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Inclusion criteria
✓. Meet the diagnostic criteria of EBV-HLH or CAEBV.
✓. Newly diagnosed patients.
✓. Eastern Cooperative Oncology Group score 0-3.
✓. Total bilirubin \<= 10 times of upper limit of normal (except for those caused by EBV-HLH or CAEBV), and serum creatinine \<= 1.5 times of upper limit of normal.
✓. Serum HIV antigen or antibody is negative.
✓. Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV-RNA is negative.
✓. Both HbsAg and HbcAb for Hepatitis B virus (HBV) are negative. If not, the quantification of HBV-DNA needs to be \<1\*10e3 IU/ml.
✓. The patient or his/her guardian must be able to understand and be willing to participate in this study, and sign the informed consent.
Exclusion criteria
✕. Non EBV-HLH or CAEBV patients.
✕. Refractory or relapsed EBV-HLH or CAEBV.
✕. Heart function above grade II (NYHA).
✕. Patients suffered from other uncontrollable active infections.
✕. Pregnant or lactating women.
What they're measuring
1
Response rate
Timeframe: 3 weeks
2
EBV-DNA viral load
Timeframe: 3 weeks
Trial details
NCT IDNCT05039580
SponsorThe First Affiliated Hospital of Soochow University