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

NCT ID: NCT05164978

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-01-01

Brief Summary

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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

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

Conditions

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Hemophagocytic Lymphohistiocytosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients with EBV- HLH receive DEP combine with PD-1 antibody as an treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DEP combine with PD-1 antibody

Intervention Type DRUG

Doxorubicin hydrochloride liposome injection 25 mg/m2 day 1 Etoposide 100 mg/m2 day1 Methylprednisolone 1.5 mg/kg days 1 to day 3, 0.25mg/kg days 4 to 14 Sintilimab Injection 200mg d4

Interventions

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DEP combine with PD-1 antibody

Doxorubicin hydrochloride liposome injection 25 mg/m2 day 1 Etoposide 100 mg/m2 day1 Methylprednisolone 1.5 mg/kg days 1 to day 3, 0.25mg/kg days 4 to 14 Sintilimab Injection 200mg d4

Intervention Type DRUG

Other Intervention Names

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DEP+PD-1

Eligibility Criteria

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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.

8\. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Wang

Department of Hematology, Beijing Friendship Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhao Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhao Wang

Role: CONTACT

86-010-63139862

Yahong You

Role: CONTACT

17810283962

Facility Contacts

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Zhao Wang, PhD

Role: primary

Other Identifiers

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DEP,PD-1, HLH

Identifier Type: -

Identifier Source: org_study_id

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