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

Beijing Friendship Hospital90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemophagocytic Lymphohistiocytosis

Interventions

EtoposideDRUG

150 mg/m2 twice weekly for 2 weeks and then weekly

DexamethasoneDRUG

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

EtoposideDRUG

150 mg/m2 weekly

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Overall response(complete response+ partial response) rate of Participants

A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25(pg/ml), ferritin(μg/L), and triglyceride(mmol/L); hemoglobin(g/L); neutrophil counts(×109/L); platelet counts(×109/L); and alanine aminotransferase (ALT(U/L)). A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25(pg/ml) response was\>1.5-fold decreased; ferritin (μg/L)and triglyceride(mmol/L) decreased at least 25%; for patients with an initial neutrophil count of\<0.5 ×109/L, a response was defined as an increase by at least 100% to\>0.5× 109/L; for patients with a neutrophil count of 0.5 to 2.0 × 109/L, an increase by at least 100% to \>2.0 × 109/L was considered a response; and for patients with ALT \>400 U/L, response was defined as an ALT (U/L)decrease of at least 50%.

Time frame: Change from before and 2,4 weeks after initiating thearpy

Secondary Outcomes

Compare survival between two arms

Time frame: from the time patients received therapy up to 12 months or December 2020

Data from ClinicalTrials.gov

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