Overview

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

Status:
Recruiting

Trial end date:
2023-01-01

Target enrollment:
0

Participant gender:
All

Summary

This study aimed to investigate the efficacy and safety of DEP (liposomal doxorubicin, etoposide and methylprednisolone) together with PD-1 antibody as an initial treatment for EBV associated hemophagocytic lymphohistiocytosis.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Beijing Friendship Hospital

Treatments:

Antibodies

Criteria

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. No HLH induction therapy was performed.

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

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

5. Serum creatinine ≤ 1.5 times normal；

6. 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.

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

8. No uncontrollable infection.

9. Contraception for both male or female.

10. 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.