DEP Combine With PD-1 Antibody as an Treatment for EBV-HLH
- Conditions
- Hemophagocytic Lymphohistiocytosis
- Interventions
- Drug: DEP combine with PD-1 antibody
- Registration Number
- NCT05164978
- Lead Sponsor
- Beijing Friendship Hospital
- Brief Summary
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.
- Detailed Description
PD-1 antibody added to the DEP regimen （with or without asparaginases） in EBV-HLH,
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; EBV-DNA in peripheral blood or EBER in tissue were positive, patients were diagnosed with EBV associated HLH (EBV-HLH).
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. The expected survival time is more than 1 month.
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Age >18 years old, gender is not limited.
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Serum creatinine ≤ 1.5 times normal；
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Serum human immunodeficiency virus(HIV) antigen or antibody negative； Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative；HBV copies less than 1E+03 copies/ml.
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No thyroid dysfunction. The left ventricular ejection fraction (LVEF) was normal.
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No uncontrollable infection.
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Contraception for both male or female.
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Informed consent obtained.
- Allergic to doxorubicin, etoposide and sintilimab Injection
- Serious immunoreaction: myocardial damage, hepatitis, pneumonia
- Central nervous system symptoms
- Serious mental illness;
- Central nervous system symptoms
- Serious mental illness;
- Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2；
- Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase;
- Participate in other clinical research at the same time.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DEP combine with PD-1 antibody DEP combine with PD-1 antibody doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered day1; methylprednisolone 1.5mg/kg days 1 to 3,then 0.25mg/kg day 4 to 14; sintilimab injection 200mg day 4. This regimen was repeated after 2 weeks.
- Primary Outcome Measures
Name Time Method Evaluation of treatment response Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy 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%.
- Secondary Outcome Measures
Name Time Method EBV-DNA Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy EBV-DNA copies/ml in peripheral blood
Survival 3 months after the intervention Outcome of patients with EBV-HLH
Adverse events that are related to treatment 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy Incidence of events that are related to treatment including myelosuppression, infection, bleeding and so on.
Trial Locations
- Locations (1)
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China