Hemophagocytic LymphohistiocytosisNCT06131489
Segmental Resection Combined With DEP Regimen for EBV-HLH Patients With Intestinal Involvement
An observational study of Hemophagocytic Lymphohistiocytosis and Epstein-Barr Virus, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
EBV-HLH is a rare disease with high mortality, especially for those with intestinal involvement. In order to reduce disease burden and improve survival of these patients, we conduct a prospective observational study to explore the efficacy and safety of segmental resection combined with the DEP regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophagocytic Lymphohistiocytosis, Epstein-Barr Virus, Bowel Resection
- What is being tested?
- Segmental bowel resection combined with the DEP regimen
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: EBV-HLH patients with intestinal involvement
Who may be able to join
- Met HLH-2004 diagnostic criteria;
- EBV-DNA in the peripheral blood > 1000 copies/ml or EBV-encoded small RNA (EBER) detected in tissues;
- Imaging revealed severe intestinal lesions and biopsy confirmed EBV-encoded small RNA (EBER) in the tissues;
- Age >18 years old, gender is not limited;
- Estimated survival time > 1 month;
- Informed consent obtained.
Who cannot join
- Active infections (viral, bacterial, fungal or parasitic);
- Diagosed with malignant tumos within 5 years；
- Uncontrolled symptoms or other diseases including, but not limited to, unstable angina pectoris, arrhythmia, respiratory failure, severe hepatic or renal insufficiency, severe coagulation dysfunction, mental illness, or other conditions deemed by the attending physician to be contraindications to surgery;
- Heart function above grade II (NYHA);
- Severe myocardial injury：TNT、TNI、CK-MB > 3 ULN;
- Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease;
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- Pregnancy or lactating Women;
- Allergic to pegylated liposomal doxorubicin and etoposide;
- HIV antibody positivity;
- Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable), acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibody positivity, HCV RNA negative acceptable);
- Participate in other clinical research at the same time;
- The researchers considered that patients are not suitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhao Wang
Beijing, Beijing Municipality, 100050
Zhao Wang, MD, 63138303, wangzhao@ccmu.edu.cn
About this study
Official title: Efficacy and Safety of Segmental Resection Combined With the DEP Regimen for Epstein-Barr Virus Associated Hemophagocytic Lymphohistiocytosis With Intestinal Involvement
EBV-HLH is a rare disease with high mortality, especially for those with intestinal involvement. In order to reduce disease burden and improve survival of these patients, we conduct a prospective observational study to explore the efficacy and safety of segmental resection combined with the DEP regimen.
Read the detailed description
Epstein-Barr virus associated hemophagocytic lymphohistiocytosis is a rare disease with high mortality, especially for those with intestinal involvement. Some of them still died despite early control of the disease due to severe complications, such as gastrointestinal bleeding. In order to reduce disease burden and improve survival of these patients, we conduct a prospective observational study to explore the efficacy and safety of segmental resection combined with the DEP regimen.
- Being tested
- Segmental bowel resection combined with the DEP regimen
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental bowel resection combined with the DEP regimenOther
Segmental bowel resection combined with liposomal doxorubicin, etoposide, and methylprednisolone administered in 2 week cycles for 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| EBV-HLH patients with intestinal involvement | Epstein-Barr virus associated hemophagocytic lymphohistiocytosis patients with imaging confirmed intestinal involvement Receives: Other: Segmental bowel resection combined with the DEP regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The percentage of cases that achieved complete response (CR) and partial response (PR) after treatment.
Measured: 4 Week
Adverse events
Incidence of adverse reactions
Measured: 1 month
Secondary outcomes (1)
OS
Overall survival rate
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophagocytic LymphohistiocytosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Wang, Beijing Friendship Hospital
- Investigators
- Zhao Wang, MD, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131489
- Sponsor's protocol ID
- BFH20230809002/BFHHZS20230190
- Status last verified
- Sep 2023
- First submitted
- 9 Nov 2023
- Last updated
- 14 Nov 2023
- 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 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Segmental Resection Combined With the DEP Regimen for Epstein-Barr Virus Associated Hemophagocytic Lymphohistiocytosis With Intestinal Involvement
- ClinicalTrials.gov ID
- NCT06131489
- Acronym / sponsor ID
- BFH20230809002/BFHHZS20230190
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 14 Nov 2023 (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 is a rare disease with high mortality, especially for those with intestinal involvement. In order to reduce disease burden and improve survival of these patients, we conduct a prospective observational study to explore the efficacy and safety of segmental resection combined with the DEP regimen.
Detailed description
Epstein-Barr virus associated hemophagocytic lymphohistiocytosis is a rare disease with high mortality, especially for those with intestinal involvement. Some of them still died despite early control of the disease due to severe complications, such as gastrointestinal bleeding. In order to reduce disease burden and improve survival of these patients, we conduct a prospective observational study to explore the efficacy and safety of segmental resection combined with the DEP regimen.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBV-HLH patients with intestinal involvement | – | Other: Segmental bowel resection combined with the DEP regimenEpstein-Barr virus associated hemophagocytic lymphohistiocytosis patients with imaging confirmed intestinal involvement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- EBV-HLH patients with intestinal involvement
Key inclusion criteria (6 listed)
- Met HLH-2004 diagnostic criteria;
- EBV-DNA in the peripheral blood > 1000 copies/ml or EBV-encoded small RNA (EBER) detected in tissues;
- Imaging revealed severe intestinal lesions and biopsy confirmed EBV-encoded small RNA (EBER) in the tissues;
- Age >18 years old, gender is not limited;
- Estimated survival time > 1 month;
Key exclusion criteria (12 listed)
- Active infections (viral, bacterial, fungal or parasitic);
- Diagosed with malignant tumos within 5 years；
- Uncontrolled symptoms or other diseases including, but not limited to, unstable angina pectoris, arrhythmia, respiratory failure, severe hepatic or renal insufficiency, severe coagulation dysfunction, mental illness, or other conditions deemed by the attending physician to be contraindications to surgery;
- Heart function above grade II (NYHA);
- Severe myocardial injury：TNT、TNI、CK-MB > 3 ULN;
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 |
|---|---|---|
| Segmental bowel resection combined with the DEP regimenSegmental bowel resection combined with liposomal doxorubicin, etoposide, and methylprednisolone administered in 2 week cycles for 2 cycles | Other | EBV-HLH patients with intestinal involvement |
Primary outcome
ORR
Time frame: 4 Week
The percentage of cases that achieved complete response (CR) and partial response (PR) after treatment.
Adverse events
Time frame: 1 month
Incidence of adverse reactions
1 secondary outcome
OS
Time frame: 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- 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.
Zhao Wang, MD principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophagocytic Lymphohistiocytosis and Epstein-Barr Virus, run by Beijing Friendship Hospital 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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 14 Nov 2023. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao Wang, MD (63138303, wangzhao@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 4 Week). 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 14 Nov 2023.