ClinicalTrials.gov record NCT06131489
Segmental Resection Combined With DEP Regimen for EBV-HLH Patients With Intestinal Involvement
Efficacy and Safety of Segmental Resection Combined With the DEP Regimen for Epstein-Barr Virus Associated Hemophagocytic Lymphohistiocytosis With Intestinal Involvement
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study follows adults with Epstein‑Barr virus–associated hemophagocytic lymphohistiocytosis (EBV‑HLH) who have intestinal involvement. It records clinical response and adverse events after segmental bowel resection combined with the DEP regimen (liposomal doxorubicin, etoposide, methylprednisolone). The study measures response at 4 weeks, adverse events at 1 month, and overall survival at 1 year.
What it is studying. The study seeks to learn about the safety and effectiveness of combining segmental bowel resection with the DEP regimen in adults who have EBV‑HLH with intestinal lesions.
What the researchers hope to learn. To describe response rates (complete and partial response), record the incidence of adverse reactions, and estimate overall survival after combined segmental resection and DEP treatment in EBV‑HLH patients with intestinal involvement.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Segmental bowel resection combined with the DEP regimen
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- 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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will undergo a segmental bowel resection (surgery) and receive the DEP regimen: pegylated liposomal doxorubicin, etoposide, and methylprednisolone given in two‑week cycles for two cycles. They will be monitored after treatment for response (primary response assessed around 4 weeks), for adverse events (reported within about 1 month), and for overall survival up to 1 year. Additional clinical assessments and tests needed for safety and outcome measurement will be performed as required by the study team.
How the study is structured. A prospective observational study: people who receive segmental bowel resection plus the DEP regimen are followed over time. Researchers collect short‑term treatment response (4 weeks), adverse events (1 month), and overall survival (1 year). No randomization or masking is described.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on hemophagocytic lymphohistiocytosis
Important dates
- Study start
- Dec 1, 2023 (estimated)
- Primary completion
- Dec 1, 2026 (estimated)
- Study completion
- Jan 1, 2027 (estimated)
- Target enrollment
- 20 participants (estimated)
- Last updated on registry
- Nov 14, 2023
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Beijing Friendship Hospital
- Principal investigator
- Zhao Wang, Professor and Head of hematology
Beijing Friendship Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Zhao Wang, MD 📞 63138303 ✉ wangzhao@ccmu.edu.cn
Participating sites (1)
- Zhao Wang
Beijing, Beijing Municipality, 100050 · China
- Zhao Wang, MD · 63138303 · wangzhao@ccmu.edu.cn
Terms used on this page · explanations by MedicalUpdates.ai
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- Informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- contraindications
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- ULN
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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