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

NCT06131489 | Not Yet Recruiting

• 1 other identifier: BFH20230809002/BFHHZS20230190
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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 observational study to explore the efficacy and safety of segmental resection combined with the DEP regimen.

Conditions

Hemophagocytic Lymphohistiocytosis; Epstein-Barr Virus; Bowel Resection

Outcome Measures

Primary Outcomes (2)

• ORR

  The percentage of cases that achieved complete response (CR) and partial response (PR) after treatment.

  4 Week

• Adverse events

  Incidence of adverse reactions

  1 month

Secondary Outcomes (1)

• OS

  1 years

Study Arms (1)

EBV-HLH patients with intestinal involvement

Epstein-Barr virus associated hemophagocytic lymphohistiocytosis patients with imaging confirmed intestinal involvement

Other: Segmental bowel resection combined with the DEP regimen

Interventions

Segmental bowel resection combined with the DEP regimen OTHER

Segmental bowel resection combined with liposomal doxorubicin, etoposide, and methylprednisolone administered in 2 week cycles for 2 cycles

EBV-HLH patients with intestinal involvement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

EBV-HLH patients with intestinal involvement

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Zhao Wang

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic; Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Zhao Wang, MD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Wang, MD

CONTACT

63138303; wangzhao@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of hematology

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)