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Programmed Cell Death Protein-1 (PD-1) Monoclonal Antibody for EBV-HLH and CAEBV as First-line Therapy (SEHC)

Primary Purpose

EBV Infection

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PD-1 monoclonal antibody
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for EBV Infection

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Meet the diagnostic criteria of EBV-HLH or CAEBV.
  2. Newly diagnosed patients.
  3. Eastern Cooperative Oncology Group score 0-3.
  4. 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.
  5. Serum HIV antigen or antibody is negative.
  6. Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV-RNA is negative.
  7. 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.
  8. The patient or his/her guardian must be able to understand and be willing to participate in this study, and sign the informed consent.

Exclusion Criteria:

  1. Non EBV-HLH or CAEBV patients.
  2. Refractory or relapsed EBV-HLH or CAEBV.
  3. Heart function above grade II (NYHA).
  4. Patients suffered from other uncontrollable active infections.
  5. Pregnant or lactating women.
  6. Patients with mental disorders and cannot cooperate with the requirements of research, treatment and monitoring.
  7. Active visceral bleeding.
  8. Allergic to PD-1 monoclonal antibody.
  9. Patients with known autoimmune diseases.
  10. Participate in other clinical research at the same time.
  11. 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.

Sites / Locations

  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD-1 monoclonal antibody group

Arm Description

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.

Outcomes

Primary Outcome Measures

Response rate
complete response and/or partial response rate
EBV-DNA viral load
EBV-DNA copy by polymerase chain reaction

Secondary Outcome Measures

Time for treatment works
Time to achieve partial response or complete response
Toxicity of PD-1 monoclonal antibody
Side effects related to immunotherapy

Full Information

First Posted
September 1, 2021
Last Updated
September 1, 2021
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT05039580
Brief Title
Programmed Cell Death Protein-1 (PD-1) Monoclonal Antibody for EBV-HLH and CAEBV as First-line Therapy
Acronym
SEHC
Official Title
A Clinical Trial of PD-1 Monoclonal Antibody as First-line Induction Therapy for EBV-associated Hemophagocytic Syndrome (EBV-HLH) or Chronic Active EBV Infection (CAEBV)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Eligible patients who were diagnosed with EBV-HLH or CAEBV, age between 12 and 70 years, were enrolled in this study. All of them need to sign the informed consent first. 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. Besides, optimal supportive care is necessary. Ruxolitinib and/or low-dose glucocorticoid can be used to reduce inflammation. Cerebrospinal fluid parameters are examined, and methotrexate 15mg combined with dexamethasone will be intrathecal injected without contraindications. Clinical and laboratory indicators are investigated weekly to evaluate the efficacy and toxicity. If patients achieve partial response/complete response within 14 days after PD-1 monoclonal antibody, the clinical observations are stopped. If not, the observation period is prolonged to 21 days. If disease progress at day 21, this study is terminated, and the patient should be transfer to other treatments as soon as quickly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EBV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD-1 monoclonal antibody group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PD-1 monoclonal antibody
Other Intervention Name(s)
ruxolitinib, dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response rate
Description
complete response and/or partial response rate
Time Frame
3 weeks
Title
EBV-DNA viral load
Description
EBV-DNA copy by polymerase chain reaction
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Time for treatment works
Description
Time to achieve partial response or complete response
Time Frame
3 weeks
Title
Toxicity of PD-1 monoclonal antibody
Description
Side effects related to immunotherapy
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefeng He, doctor
Phone
86-18914031640
Email
hexuefeng@suda.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoli Li, doctor
Phone
86-13625270981
Email
397640784@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuefeng He, doctor
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefeng He, doctor
Phone
86-18914031640
Email
hexuefeng@suda.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaoli Li, doctor
Phone
86-13625270981
Email
397640784@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Programmed Cell Death Protein-1 (PD-1) Monoclonal Antibody for EBV-HLH and CAEBV as First-line Therapy

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