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

Launched by BEIJING FRIENDSHIP HOSPITAL · Nov 9, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment approach for patients with a rare and serious condition called Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis (EBV-HLH), particularly those who have issues with their intestines. The study aims to see how effective and safe a combination of a specific surgery (called segmental resection) and a treatment regimen known as DEP can be in helping these patients. EBV-HLH can be life-threatening, so this research is important for improving care and survival for those affected.

To be eligible for this trial, participants need to be over 18 years old and meet certain health criteria, such as having a confirmed diagnosis of EBV-HLH and significant intestinal problems shown through imaging tests. They also need to have a certain level of the virus in their blood. However, people with active infections, recent cancer diagnoses, or serious heart and other health issues may not qualify. If accepted, participants will be closely monitored throughout the study to assess how well the treatment works and to ensure their safety. This trial is currently not recruiting participants, but it will provide valuable information for future treatments.

Gender

ALL

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.