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L-DEP as an Initial Treatment for EBV-HLH

NCT02912702 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-09-23

No results posted yet for this study

Summary

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.

Conditions

  • Hemophagocytic Lymphohistiocytosis

Interventions

DRUG

Pegaspargase

2000U/m2 day5

DRUG

doxorubicin hydrochloride liposome injection

25 mg/m2 day 1

DRUG

etoposide

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

DRUG

methylprednisolone

15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7

DRUG

Etoposide

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

DRUG

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

Sponsors & Collaborators

  • Beijing Friendship Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-09-30
Completion
2019-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02912702 on ClinicalTrials.gov