L-DEP as an Initial Treatment for EBV-HLH

Beijing Friendship Hospital120 enrolled

Overview

This study aimed to investigate the efficacy and safety of Pegaspargase together with liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as an initial treatment for Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Hemophagocytic Lymphohistiocytosis

Interventions

PegaspargaseDRUG

2000U/m2 day5

doxorubicin hydrochloride liposome injectionDRUG

25 mg/m2 day 1

etoposideDRUG

100 mg/m2 was administered once on the first day of every week

Eligibility

Sex: ALLMin age: 14 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients were older than 14 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

RECRUITING

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 2,4,6 and 8 weeks after initiating L-DEP or HLH-94 therapy

Secondary Outcomes

Compare survival between two arms

Time frame: from the time patients received L-DEP or HLH-94 therapy up to 12 months or September 2019

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Adverse events including pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on.

Time frame: through study completion, an average of 1 years

Change of Epstein-Barr virus(EBV)-DNA before and after therapy

Time frame: Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP or HLH-94 therapy

Central Contacts

jingshi wang, M.M.

CONTACT

86-13520280731 wangjingshi987@sina.com

Data from ClinicalTrials.gov

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