DEP Combine With PD-1 Antibody as an Treatment for EBV-HLH

Capital Medical University

Status: Unknown

Conditions: Hemophagocytic Lymphohistiocytosis

Treatments: Drug: DEP combine with PD-1 antibody

Study type: Interventional

Funder types: Other

Identifiers

NCT05164978

DEP,PD-1, HLH

Details and patient eligibility

About

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.

Full description

PD-1 antibody added to the DEP regimen （with or without asparaginases） in EBV-HLH,

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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).

2. . The expected survival time is more than 1 month.

3. Age >18 years old, gender is not limited.

4. Serum creatinine ≤ 1.5 times normal；

5. 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.

6. No thyroid dysfunction. The left ventricular ejection fraction (LVEF) was normal.

7. No uncontrollable infection.

8. Contraception for both male or female.

9. Informed consent obtained.

Exclusion criteria

1. Allergic to doxorubicin, etoposide and sintilimab Injection
2. Serious immunoreaction: myocardial damage, hepatitis, pneumonia
3. Central nervous system symptoms
4. Serious mental illness;
5. Central nervous system symptoms
6. Serious mental illness;
7. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2；
8. Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase;
9. Participate in other clinical research at the same time.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

DEP combine with PD-1 antibody

Experimental group

Description:

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.

Treatment:

Drug: DEP combine with PD-1 antibody