L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis

NCT ID: NCT02631109

Last Updated: 2016-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-11-30

Brief Summary

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

Detailed Description

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Conditions

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Hemophagocytic Lymphohistiocytosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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L-DEP

Pegaspargase 2000U/m2 day5; doxorubicin (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

Group Type EXPERIMENTAL

Pegaspargase

Intervention Type DRUG

2000U/m2 day5

doxorubicin

Intervention Type DRUG

25mg/m2 day1

etoposide

Intervention Type DRUG

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

methylprednisolone

Intervention Type DRUG

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

Interventions

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Pegaspargase

2000U/m2 day5

Intervention Type DRUG

doxorubicin

25mg/m2 day1

Intervention Type DRUG

etoposide

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

Intervention Type DRUG

methylprednisolone

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients were older than 14 years of age
2. Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH)
3. Patients did not achieve at lease partial response after initial treatment including HLH-94 or DEP no less than 2 weeks
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
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Wang

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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zhao wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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jingshi wang, M.M.

Role: CONTACT

86-13520280731

Facility Contacts

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jingshi wang, M.M.

Role: primary

86-13520280731

References

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Wang Y, Huang W, Hu L, Cen X, Li L, Wang J, Shen J, Wei N, Wang Z. Multicenter study of combination DEP regimen as a salvage therapy for adult refractory hemophagocytic lymphohistiocytosis. Blood. 2015 Nov 5;126(19):2186-92. doi: 10.1182/blood-2015-05-644914. Epub 2015 Aug 19.

Reference Type BACKGROUND
PMID: 26289641 (View on PubMed)

Wang J, Wang Y, Wu L, Zhang J, Lai W, Wang Z. PEG-aspargase and DEP regimen combination therapy for refractory Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis. J Hematol Oncol. 2016 Sep 9;9(1):84. doi: 10.1186/s13045-016-0317-7.

Reference Type DERIVED
PMID: 27613189 (View on PubMed)

Other Identifiers

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L-DEP-EBV-HLH

Identifier Type: -

Identifier Source: org_study_id

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