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

ConditionsHemophagocytic LymphohistiocytosisEpstein-Barr VirusBowel Resection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Friendship Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial population

EBV-HLH patients with intestinal involvement

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Segmental bowel resection combined with the DEP regimen

    Other intervention

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: EBV-HLH patients with intestinal involvement1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: