Etoposide in the First-line Treatment of Adult EBV-HLH

Capital Medical University

Status and phase: Unknown; Phase 3

Conditions: Hemophagocytic Lymphohistiocytosis

Treatments: Drug: IVIG; Drug: Dexamethasone; Drug: Etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT03742115

VP-16-adult EBV-HLH-first line

Details and patient eligibility

About

his study aimed to investigate the efficacy of etoposide as the first line therapy for adult Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients were older than 18 years of age
2. Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH)
3. Patients did not receive any treatment for HLH before
4. Informed consent

Exclusion criteria

1. Heart function above grade II (NYHA)
2. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2
3. Pregnancy or lactating Women
4. Allergic to Pegaspargase, doxorubicin or etoposide
5. Active bleeding of the internal organs
6. uncontrollable infection
7. history of acute and chronic pancreatitis
8. Participate in other clinical research at the same time

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Etoposide standard group

Experimental group

Description:

Etoposide 150 mg/m2 twice weekly for 2 weeks and then weekly; dexamethasone initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering

Treatment:

Drug: Dexamethasone

Drug: Etoposide

Drug: Etoposide

Etoposide reduction group

Experimental group

Description:

Etoposide 150 mg/m2 once a week; dexamethasone initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering

Treatment:

Drug: Dexamethasone

Drug: Etoposide

Drug: Etoposide

Corticosteroid group

Active Comparator group

Description:

dexamethasone initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering, with or without IvIG (0.5 g/kg IV, once every 4 weeks)

Treatment:

Drug: IVIG

Drug: Dexamethasone