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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    20
  • sponsor
    Beijing Friendship Hospital
Updated on 16 March 2022

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.

Description

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

Details
Condition Hemophagocytic Lymphohistiocytosis
Treatment DEP combine with PD-1 antibody
Clinical Study IdentifierNCT05164978
SponsorBeijing Friendship Hospital
Last Modified on16 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
The expected survival time is more than 1 month
Age >18 years old, gender is not limited
Serum creatinine ≤ 1.5 times normal;
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
No thyroid dysfunction. The left ventricular ejection fraction (LVEF) was normal
No uncontrollable infection
Contraception for both male or female
Informed consent obtained

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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