EBV InfectionPhase 4SEHCNCT05039580
Programmed Cell Death Protein-1 (PD-1) Monoclonal Antibody for EBV-HLH and CAEBV as First-line Therapy
A Phase 4 study testing PD-1 monoclonal antibody in people with EBV Infection, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- EBV Infection
- What is being tested?
- PD-1 monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2021to 30 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xuefeng He, doctor, 86-18914031640, hexuefeng@suda.edu.cn
Xiaoli Li, doctor, 86-13625270981, 397640784@qq.com
About this study
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)
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.
Read the 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.
- Conditions
- EBV Infection
- Being tested
- PD-1 monoclonal antibody
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 monoclonal antibodyDrug
Also called ruxolitinib, dexamethasone
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
complete response and/or partial response rate
Measured: 3 weeks
EBV-DNA viral load
EBV-DNA copy by polymerase chain reaction
Measured: 3 weeks
Secondary outcomes (2)
Time for treatment works
Time to achieve partial response or complete response
Measured: 3 weeks
Toxicity of PD-1 monoclonal antibody
Side effects related to immunotherapy
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start15 May 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV InfectionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuefeng He, doctor, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039580
- Sponsor's protocol ID
- EBV and CAEBV 001
- Acronym
- SEHC
- Status last verified
- Jul 2021
- First submitted
- 1 Sep 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05039580
- Acronym / sponsor ID
- SEHC / EBV and CAEBV 001
- Conditions
- EBV Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 monoclonal antibody group | Experimental | Drug: PD-1 monoclonal antibodyPD-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. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 monoclonal antibodyAlso: ruxolitinib, dexamethasonePD-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. | Drug | PD-1 monoclonal antibody group |
Primary outcome
Response rate
Time frame: 3 weeks
complete response and/or partial response rate
EBV-DNA viral load
Time frame: 3 weeks
EBV-DNA copy by polymerase chain reaction
2 secondary outcomes
Time for treatment works
Time frame: 3 weeks
Toxicity of PD-1 monoclonal antibody
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuefeng He, doctor principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PD-1 monoclonal antibody in people with EBV Infection, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuefeng He, doctor (86-18914031640, hexuefeng@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.