NCT02912702

L-DEP as an Initial Treatment for EBV-HLH

A Randomized Controlled Trial of L-DEP as an Initial Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-09-01
• Completion: 2019-09-01
• First posted: 2016-09-23
• Last updated: 2016-09-23

Locations

1 site across 1 country: China