An observational study in Secondary Hemophagocytic Lymphohistiocytosis and Chronic Active Epstein-Barr Virus Infection, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 2 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Beijing Friendship Hospital · Observational
This prospective case-control study aims to evaluate the immune function and find PD-1 antibody efficacy predictors on Chronic Active Epstein-Barr Virus Infection and Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis by detecting lymphocyte subsets proportions in peripheral blood mononuclear cells and the positive proportion of PD-1, PD-L1 and other indicators in each lymphocyte subsets in healthy people and patients using flow cytometry before and after the initial PD-1 therapy.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 128 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.
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Healthy people and patients with CAEBV or secondary EBV-HLH.
Exclusion Criteria:
Healthy male or female aged 2-80 years with negative EBV-DNA quantitative test results within the last week.
Other: No intervention
Patients aged 2-80 years who fulfilled the diagnostic criteria for CAEBV or EBV-HLH. The diagnostic criteria for CAEBV as defined in the recently revised World Health Organization classification include persistent IM-like symptoms for more than three months, increased EBV DNA (\>10\^2.5 copies/mg) in peripheral blood, histological evidence of organ disease, and EBV RNA or viral protein in affected tissues. Patients diagnosed with EBV-HLH must meet five of the following eight HLH-2004 diagnostic criteria: 1. temperature 38.5 ℃ and above; 2. splenomegaly; 3. two or three lines of hemocytopenia, i.e. hemoglobin (HB) \<90 g/L, platelets (PLT) \<100 × 10\^9/L or neutrophils (N) \<1 × 10\^9/L; 4. triacylglycerol (TG) ≥ 3 mmol/ L or fibrinogen (Fbg) \<1.5 g/L; 5. serum ferritin (SF) ≥ 500 mg/L; 6. phagocytosis found in bone marrow, spleen, liver or lymph nodes; 7. soluble CD25 (sCD25) ≥ 2400 U/mL; 8. low or absent natural killer (NK) cell activity.
Other: No intervention
No intervention
EBV-DNA
Treatment effectiveness is defined: EBV-DNA copies/ml in peripheral blood turns negative, and the involved tissues (such as lymph nodes, bone marrow, skin, etc.) are negative in EBER test or the EBV copy number has decreased by more than 2 orders of magnitude, but it is still positive.
Time frame: Change from before and 2 weeks after initiating PD-1 blockade therapy.
CAEBV Evaluation of treatment response
Complete response (CR) was defined as EBV-DNA copy number below the lower limit of detection (\<5.0×10\^2 copies/ml) for at least 4 weeks. Partial response (PR) was defined as ≤ 1/100 reduction in EBV-DNA copy number, and the CR criterion was not met. Failure to achieve at least PR was defined as no response (NR). Besides, the main clinical manifestation of CAEBV, including fever, asthenia, liver damage (elevation of ALT and AST), skin rash, cytopenia and lymphadenopathy was also evaluated.
Time frame: Change from before and 2 weeks after initiating PD-1 blockade therapy.
EBV-HLH Evaluation of treatment response
A complete response (CR) was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT). A partial response (PR) was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was\>1.5-fold decreased; ferritin and triglyceride decreased at least 25%; for patients with an initial neutrophil count of\<0.5 ×10\^9/L, a response was defined as an increase by at least 100% to\>0.5×10\^9/L; for patients with a neutrophil count of 0.5 to 2.0× 109/L, an increase by at least 100% to \>2.0 × 10\^9/L was considered a response; and for patients with ALT \>400 U/L, response was defined as an ALT decrease of at least 50%.
Time frame: Change from before and 2 weeks after initiating PD-1 blockade therapy.
Progression Free Survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: 6 months
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Beijing Friendship Hospital