L-DEP as an Initial Treatment for EBV-HLH

Capital Medical University

Status and phase: Unknown; Phase 3

Conditions: Hemophagocytic Lymphohistiocytosis

Treatments: Drug: Pegaspargase; Drug: Etoposide; Drug: dexamethasone; Drug: etoposide; Drug: doxorubicin hydrochloride liposome injection; Drug: methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02912702

L-DEP-EBV-HLH-First line

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

L-DEP

Experimental group

Description:

Pegaspargase 2000U/m2 day5; doxorubicin hydrochloride liposome injection 25 mg/m2 day 1; etoposide 100 mg/m2 was administered once on the first day of every week; methylprednisolone 15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7

Treatment:

Drug: doxorubicin hydrochloride liposome injection

Drug: etoposide

Drug: methylprednisolone

Drug: Pegaspargase

HLH-94 regimen

Active Comparator 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