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Trial Title:
Segmental Resection Combined With DEP Regimen for EBV-HLH Patients With Intestinal Involvement
NCT ID:
NCT06131489
Condition:
Hemophagocytic Lymphohistiocytosis
Epstein-Barr Virus
Bowel Resection
Conditions: Official terms:
Epstein-Barr Virus Infections
Lymphohistiocytosis, Hemophagocytic
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Segmental bowel resection combined with the DEP regimen
Description:
Segmental bowel resection combined with liposomal doxorubicin, etoposide, and
methylprednisolone administered in 2 week cycles for 2 cycles
Arm group label:
EBV-HLH patients with intestinal involvement
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.
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.
Criteria for eligibility:
Study pop:
EBV-HLH patients with intestinal involvement
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhao Wang
Address:
City:
Beijing
Zip:
100050
Country:
China
Contact:
Last name:
Zhao Wang, MD
Phone:
63138303
Email:
wangzhao@ccmu.edu.cn
Start date:
December 1, 2023
Completion date:
January 1, 2027
Lead sponsor:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Beijing Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06131489
