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

NCT05164978 | Unknown DMC

• 1 other identifier: DEP,PD-1, HLH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophagocytic Lymphohistiocytosis

Keywords

Hemophagocytic Lymphohistiocytosis; DEP; PD-1 antibody

Outcome Measures

Primary Outcomes (1)

• Evaluation of treatment response

  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%.

  Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy

Secondary Outcomes (3)

• EBV-DNA

  Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy

• Survival

  3 months after the intervention

• Adverse events that are related to treatment

  2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy

Study Arms (1)

DEP combine with PD-1 antibody

EXPERIMENTAL

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.

Drug: DEP combine with PD-1 antibody

Interventions

DEP combine with PD-1 antibody 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

Also known as: DEP+PD-1

DEP combine with PD-1 antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zhao Wang

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Wang

CONTACT

86-010-63139862; wangzhao@ccmu.edu.cn

Yahong You

CONTACT

17810283962; 15332022659@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Hematology, Beijing Friendship Hospital

Model Details: All patients with EBV- HLH receive DEP combine with PD-1 antibody as an treatment.

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: December 21, 2021
• Study Start: May 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)