Clinical trial · Observational
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
NCT06131489CI-TRIAL-00071337not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bowel Resection | — | UNRESOLVED | — |
| Epstein-Barr Virus | — | UNRESOLVED | — |
| Hemophagocytic Lymphohistiocytosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Segmental bowel resection combined with the DEP regimen | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EBV-HLH patients with intestinal involvement
- description
- Epstein-Barr virus associated hemophagocytic lymphohistiocytosis patients with imaging confirmed intestinal involvement
- interventionNames
- Other: Segmental bowel resection combined with the DEP regimen
Primary outcomes (2)
- measure
- ORR
- timeFrame
- 4 Week
- description
- The percentage of cases that achieved complete response (CR) and partial response (PR) after treatment.
- measure
- Adverse events
- timeFrame
- 1 month
- description
- Incidence of adverse reactions
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.