This study aimed to investigate the efficacy and safety of DEP (liposomal doxorubicin, etoposide and methylprednisolone) together with PD-1 antibody as an treatment for EBV associated hemophagocytic lymphohistiocytosis.
PD-1 antibody added to the DEP regimen （with or without asparaginases） in EBV-HLH,
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Doxorubicin hydrochloride liposome injection 25 mg/m2 day 1 Etoposide 100 mg/m2 day1 Methylprednisolone 1.5 mg/kg days 1 to day 3, 0.25mg/kg days 4 to 14 Sintilimab Injection 200mg d4
Beijing Friendship Hospital, Capital Medical University
Beijing, China
RECRUITINGEvaluation of treatment response
The primary observed endpoint is the objective remission rate (ORR): cases that include complete remission (CR) and partial remission (PR).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). 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 ×109/L, a response was defined as an increase by at least 100% to\>0.5× 109/L; for patients with a neutrophil count of 0.5 to 2.0 × 109/L, an increase by at least 100% to \>2.0 × 109/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 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy
EBV-DNA
EBV-DNA copies/ml in peripheral blood
Time frame: Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy
Survival
Outcome of patients with EBV-HLH
Time frame: 3 months after the intervention
Adverse events that are related to treatment
Incidence of events that are related to treatment including myelosuppression, infection, bleeding and so on.
Time frame: 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy
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