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

• Sponsor: The First Affiliated Hospital of Soochow University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05039580
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23.5
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
EBV Infection	Drug: PD-1 monoclonal antibody	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: May 15, 2021
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PD-1 monoclonal antibody group 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; 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.; Other Names: ruxolitinib dexamethasone

Outcome Measures

Primary Outcome Measures

1. Response rate [3 weeks]

   complete response and/or partial response rate

2. EBV-DNA viral load [3 weeks]

   EBV-DNA copy by polymerase chain reaction

Secondary Outcome Measures

1. Time for treatment works [3 weeks]

   Time to achieve partial response or complete response

2. Toxicity of PD-1 monoclonal antibody [3 weeks]

   Side effects related to immunotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006

Sponsors and Collaborators

• The First Affiliated Hospital of Soochow University

Investigators

• Principal Investigator: Xuefeng He, doctor, The First Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Affiliated Hospital of Soochow University
• ClinicalTrials.gov Identifier: NCT05039580
• Other Study ID Numbers: EBV and CAEBV 001
• First Posted: Sep 9, 2021
• Last Update Posted: Sep 9, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Epstein-Barr Virus Infections; Dexamethasone; Antibodies; Antibodies, Monoclonal

Study Results

No Results Posted as of Sep 9, 2021