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L-DEP as an Initial Treatment for EBV-HLH

Primary Purpose

Hemophagocytic Lymphohistiocytosis

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pegaspargase
doxorubicin hydrochloride liposome injection
etoposide
methylprednisolone
Etoposide
dexamethasone
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophagocytic Lymphohistiocytosis focused on measuring Pegaspargase, hemophagocytic lymphohistiocytosis, Epstein Barr virus, initial treatment

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beijing Friendship Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

L-DEP

HLH-94 regimen

Arm 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

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

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Compare survival between two arms
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.
Change of Epstein-Barr virus(EBV)-DNA before and after therapy

Full Information

First Posted
September 9, 2016
Last Updated
September 21, 2016
Sponsor
Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02912702
Brief Title
L-DEP as an Initial Treatment for EBV-HLH
Official Title
A Randomized Controlled Trial of L-DEP as an Initial Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophagocytic Lymphohistiocytosis
Keywords
Pegaspargase, hemophagocytic lymphohistiocytosis, Epstein Barr virus, initial treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-DEP
Arm Type
Experimental
Arm 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
Arm Title
HLH-94 regimen
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Intervention Description
2000U/m2 day5
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride liposome injection
Intervention Description
25 mg/m2 day 1
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
100 mg/m2 was administered once on the first day of every week
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
150 mg/m2 twice weekly for 2 weeks and then weekly
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall response(complete response+ partial response) rate of Participants
Description
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 Outcome Measure Information:
Title
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
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Adverse events including pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on.
Time Frame
through study completion, an average of 1 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients were older than 14 years of age Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH) Patients did not receive any treatment for HLH before Informed consent Exclusion Criteria: Heart function above grade II (NYHA) Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2 Pregnancy or lactating Women Allergic to Pegaspargase, doxorubicin or etoposide Active bleeding of the internal organs uncontrollable infection history of acute and chronic pancreatitis Participate in other clinical research at the same time
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jingshi wang, M.M.
Phone
86-13520280731
Email
wangjingshi987@sina.com
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jingshi wang, M.M.
Phone
86-13520280731
Email
wangjingshi987@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26289641
Citation
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.
Results Reference
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L-DEP as an Initial Treatment for EBV-HLH

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