Status:
NOT_YET_RECRUITING
Segmental Resection Combined With DEP Regimen for EBV-HLH Patients With Intestinal Involvement
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Hemophagocytic Lymphohistiocytosis
Epstein-Barr Virus
Eligibility:
All Genders
18+ years
Brief 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 obse...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06131489
Start Date
December 1 2023
End Date
January 1 2027
Last Update
November 14 2023
Active Locations (1)
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1
Zhao Wang
Beijing, Beijing Municipality, China, 100050