Back to resultsLow-dose IL-2 ( Interleukin-2) Treatment in Macrophage Activation Syndrome（MAS）
Primary Purpose
Macrophage Activation Syndrome
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Interleukin-2
Sponsored by
About this trial
This is an interventional treatment trial for Macrophage Activation Syndrome
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Macrophage Activation Syndrome（MAS）
- MAS secondary to autoimmune disease, such as Adult onset still's disease (AOSD), juvenile rheumatoid arthritis (JRA) or Systemic Lupus Erythematosus (SLE).
Exclusion Criteria:
- Primary MAS
- Secondary to neoplasia, lymphoma and virus infection
- pre-treatment with Cyclosporine A
- relevant cardiac, pulmonary, neurologic or psychiatric disease
- life-Vaccination within 4 weeks before begin with study medication
- pregnant or breast-feeding
- weight under 45kg or more than 80kg
Sites / Locations
- Department of Rheumatology and Immunology, Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low-does rhIL-2 therapy
Arm Description
Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks
Outcomes
Primary Outcome Measures
Disease activity on the HScore (a Score for the Diagnosis of Reactive Hemophagocytic Syndrome)
Examination of the therapeutic effects (improvement in HScore) of low dose IL-2 in patients with MAS
Secondary Outcome Measures
Full Information
NCT ID
NCT02569463
First Posted
October 2, 2015
Last Updated
October 4, 2015
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02569463
Brief Title
Low-dose IL-2 ( Interleukin-2) Treatment in Macrophage Activation Syndrome（MAS）
Official Title
Safety and Efficiency Study of Low-dose IL-2 Treatment in Macrophage Activation Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators evaluate the effectiveness and safeness of low-dose Recombinant Human Interleukin-2 （rhIL-2） for MAS.
Detailed Description
Autoimmune-associated macrophage activation syndrome (MAS), also known as secondary hemophagocytic lymphohistiocytosis (HLH), is a rapidly progressing life-threatening disease. VP16 (Etoposide) is a well-known standard therapy, but is associated with substantial adverse effects, especially myelosuppression and infections , while steroids and ciclosporin (CSA) are not always efficient in this disease.
The investigators hypothesized that low- dose IL-2 could be a novel therapy in MAS. This clinical study will test the efficacy and safety of low dose IL-2 treatment in MAS. The investigators perform a single-centre pilot trial with rhIL-2 in MAS. The investigators evaluate the effectiveness and safeness of low-dose IL-2 for MAS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macrophage Activation Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-does rhIL-2 therapy
Arm Type
Experimental
Arm Description
Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Other Intervention Name(s)
Recombinant Human Interleukin-2
Intervention Description
Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks.
Primary Outcome Measure Information:
Title
Disease activity on the HScore (a Score for the Diagnosis of Reactive Hemophagocytic Syndrome)
Description
Examination of the therapeutic effects (improvement in HScore) of low dose IL-2 in patients with MAS
Time Frame
1month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Macrophage Activation Syndrome（MAS）
MAS secondary to autoimmune disease, such as Adult onset still's disease (AOSD), juvenile rheumatoid arthritis (JRA) or Systemic Lupus Erythematosus (SLE).
Exclusion Criteria:
Primary MAS
Secondary to neoplasia, lymphoma and virus infection
pre-treatment with Cyclosporine A
relevant cardiac, pulmonary, neurologic or psychiatric disease
life-Vaccination within 4 weeks before begin with study medication
pregnant or breast-feeding
weight under 45kg or more than 80kg
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing He, MD
Phone
8618611707347
Email
hejing1105@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanguo Li
Organizational Affiliation
Department of Rheumatology and Immunology,Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology and Immunology, Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing He, MD, PhD
Phone
+8618611707347
Email
hejing1105@126.com
12. IPD Sharing Statement
Learn more about this trial
Low-dose IL-2 ( Interleukin-2) Treatment in Macrophage Activation Syndrome（MAS）
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