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Not yet recruiting NCT06131489

Segmental Resection Combined With DEP Regimen for EBV-HLH Patients With Intestinal Involvement

— Observational Hemophagocytic Lymphohistiocytosis Epstein-Barr Virus Bowel Resection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Segmental bowel resection combined with the DEP regimen.
Who it may be relevant to
Registry conditions: Hemophagocytic Lymphohistiocytosis, Epstein-Barr Virus, Bowel Resection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of Segmental Resection Combined With the DEP Regimen for Epstein-Barr Virus Associated Hemophagocytic Lymphohistiocytosis With Intestinal Involvement

Overview

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.

Interventions

  • Other Segmental bowel resection combined with the DEP regimen
    Segmental bowel resection combined with liposomal doxorubicin, etoposide, and methylprednisolone administered in 2 week cycles for 2 cycles

Primary outcome measures

  • ORR [Time frame: 4 Week]
  • Adverse events [Time frame: 1 month]
Secondary outcome measures (1)
  • OS [Time frame: 1 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • Zhao Wang — Beijing

Identifiers

NCT: NCT06131489 · BFH20230809002/BFHHZS20230190

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗