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Not yet recruitingNCT06131489Updated Nov 14, 2023

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

An observational study in Hemophagocytic Lymphohistiocytosis, Epstein-Barr Virus and Bowel Resection, sponsored by Beijing Friendship Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-14.

Sponsored by Beijing Friendship Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hemophagocytic Lymphohistiocytosis
  • Epstein-Barr Virus
  • Bowel Resection
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In context

Epstein-Barr Virus Infections

159 studies on the registry are indexed under Epstein-Barr Virus Infections; 55 are open to participants now.

This study's planned enrollment of 20 is below the median of 140 across 43 observational studies indexed under Epstein-Barr Virus Infections.

Browse Epstein-Barr Virus Infections studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

EBV-HLH patients with intestinal involvement

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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherSegmental bowel resection combined with the DEP regimen

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

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What researchers measure

Primary outcomes

  1. ORR

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

    Time frame: 4 Week

  2. Adverse events

    Incidence of adverse reactions

    Time frame: 1 month

Secondary outcomes

  1. OS

    Overall survival rate

    Time frame: 1 years

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06131489
Lead sponsor
Beijing Friendship Hospital
Responsible party
Zhao Wang (Professor and Head of hematology, Beijing Friendship Hospital) — Principal investigator
First posted
Nov 14, 2023
Start date
Dec 1, 2023 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Nov 14, 2023

Study contacts

Zhao Wang, MD
Contact
wangzhao@ccmu.edu.cn
63138303
Zhao Wang, MD
principal investigator · Beijing Friendship Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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