search
Back to results

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

Primary Purpose

Hemophagocytic Lymphohistiocytosis

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pegaspargase
doxorubicin
etoposide
methylprednisolone
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

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 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

Sites / Locations

  • Beijing Friendship Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

L-DEP

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of treatment response
A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT). A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was>1.5-fold decreased; ferritin and triglyceride 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 decrease of at least 50%.
Change of Epstein-Barr virus(EBV)-DNA

Secondary Outcome Measures

Survival
Adverse events that are related to treatment
Adverse events including pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on.

Full Information

First Posted
December 3, 2015
Last Updated
August 3, 2016
Sponsor
Beijing Friendship Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02631109
Brief Title
L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis
Official Title
L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 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 a salvage therapy for refractory 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-DEP
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Intervention Description
2000U/m2 day5
Intervention Type
Drug
Intervention Name(s)
doxorubicin
Intervention Description
25mg/m2 day1
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
Primary Outcome Measure Information:
Title
Evaluation of treatment response
Description
A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT). A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was>1.5-fold decreased; ferritin and triglyceride 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 decrease of at least 50%.
Time Frame
Change from before and 2,4,6 and 8 weeks after initiating L-DEP salvage therapy
Title
Change of Epstein-Barr virus(EBV)-DNA
Time Frame
Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP salvage therapy
Secondary Outcome Measure Information:
Title
Survival
Time Frame
from the time patients received L-DEP salvage therapy up to 24 months or November 2019
Title
Adverse events that are related to treatment
Description
Adverse events including pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on.
Time Frame
through study completion, an average of 2 years

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 achieve at lease partial response after initial treatment including HLH-94 or DEP no less than 2 weeks 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhao wang, M.D.
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
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

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
background
PubMed Identifier
27613189
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs