Segmental Resection Combined With DEP Regimen for EBV-HLH... | NCT06131489

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

NCT06131489

Sponsor

Beijing Friendship Hospital

Status

Not yet recruiting

Last Update Posted

Nov 14, 2023Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Hemophagocytic Lymphohistiocytosis
Epstein-Barr Virus
Bowel Resection

Interventions

Segmental bowel resection combined with the DEP regimen

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Nov 9, 2023

First Submission Date that Met QC Criteria

Nov 9, 2023

First Posted Date

Nov 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2023

Last Update Posted Date

Nov 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
OS	Overall survival rate	1 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

EBV-HLH patients with intestinal involvement

Sampling Method

Non-Probability Sample

ID	Term
D051359	Lymphohistiocytosis, Hemophagocytic
D020031	Epstein-Barr Virus Infections

ID	Term
D015616	Histiocytosis, Non-Langerhans-Cell
D015614	Histiocytosis
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases