NCT05039580

Brief Summary

EBV-HLH and CAEBV are both caused by EBV infection, part of them can rapidly lead to a syndrome of severe, life-threatening hyper-inflammation, with poor prognosis. Currently, the most effective treatment remains unknown. This study is trying to evaluate the efficacy and safety of PD-1 monoclonal antibody as a first-line therapy for EBV-HLH and CAEBV.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

September 9, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

September 1, 2021

Last Update Submit

September 1, 2021

Conditions

EBV Infection

Outcome Measures

Primary Outcomes (2)

  • Response rate

    complete response and/or partial response rate

    3 weeks

  • EBV-DNA viral load

    EBV-DNA copy by polymerase chain reaction

    3 weeks

Secondary Outcomes (2)

  • Time for treatment works

    3 weeks

  • Toxicity of PD-1 monoclonal antibody

    3 weeks

Study Arms (1)

PD-1 monoclonal antibody group

EXPERIMENTAL

PD-1 monoclonal antibody 200mg is infused intravenously once for patients whose age \>=18 years, or age \<18 years but weight \>=40kg. While for patients age \<18 years, the dose of PD-1 monoclonal antibody is 3mg/kg.

Drug: PD-1 monoclonal antibody

Interventions

PD-1 monoclonal antibodyDRUG

PD-1 monoclonal antibody is a new attempt treatment, and ruxolitinib and/or low-dose dexamethasone can reduce the inflammation that occur in EBV-HLH or CAEBV.

Also known as: ruxolitinib, dexamethasone
PD-1 monoclonal antibody group

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the diagnostic criteria of EBV-HLH or CAEBV.
  • Newly diagnosed patients.
  • Eastern Cooperative Oncology Group score 0-3.
  • Total bilirubin \<= 10 times of upper limit of normal (except for those caused by EBV-HLH or CAEBV), and serum creatinine \<= 1.5 times of upper limit of normal.
  • Serum HIV antigen or antibody is negative.
  • Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV-RNA is negative.
  • Both HbsAg and HbcAb for Hepatitis B virus (HBV) are negative. If not, the quantification of HBV-DNA needs to be \<1\*10e3 IU/ml.
  • The patient or his/her guardian must be able to understand and be willing to participate in this study, and sign the informed consent.

You may not qualify if:

  • Non EBV-HLH or CAEBV patients.
  • Refractory or relapsed EBV-HLH or CAEBV.
  • Heart function above grade II (NYHA).
  • Patients suffered from other uncontrollable active infections.
  • Pregnant or lactating women.
  • Patients with mental disorders and cannot cooperate with the requirements of research, treatment and monitoring.
  • Active visceral bleeding.
  • Allergic to PD-1 monoclonal antibody.
  • Patients with known autoimmune diseases.
  • Participate in other clinical research at the same time.
  • The investigator judges that the patient has other reasons not suitable for this study, or participating in the study will bring great risks to the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Epstein-Barr Virus Infections

Interventions

spartalizumabruxolitinibDexamethasone

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Xuefeng He, doctor

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuefeng He, doctor

CONTACT

86-18914031640hexuefeng@suda.edu.cn

Xiaoli Li, doctor

CONTACT

86-13625270981397640784@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 9, 2021

Study Start

May 15, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

September 9, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)