This study aimed to investigate the efficacy and safety of L-DEP (L-Asparaginasum, liposomal doxorubicin, etoposide and methylprednisolone) together with PD-1 antibody as an treatment for relapse/refractory 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
50
Doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered day1; methylprednisolone 2mg/kg days 1 to 3,then 0.25mg/kg day 4 to 14; PD-1 antibody injection 200mg day 5; L-asparaginases 6000iu/m2 day2, day4. This regimen was repeated after 2 weeks.
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Evaluation 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
Outcome of patients with EBV-HLH
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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