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Low-dose IL-2 ( Interleukin-2) Treatment in Macrophage Activation Syndrome（MAS）

Sponsor
Peking University People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02569463
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
48
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators evaluate the effectiveness and safeness of low-dose Recombinant Human Interleukin-2 （rhIL-2） for MAS.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficiency Study of Low-dose IL-2 Treatment in Macrophage Activation Syndrome
Study Start Date :
Jun 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low-does rhIL-2 therapy

Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks

Drug: Interleukin-2
Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks.
Other Names:
  • Recombinant Human Interleukin-2

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease activity on the HScore (a Score for the Diagnosis of Reactive Hemophagocytic Syndrome) [1month]

      Examination of the therapeutic effects (improvement in HScore) of low dose IL-2 in patients with MAS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Rheumatology and Immunology, Peking University People's Hospital Beijing Beijing China 100044

    Sponsors and Collaborators

    • Peking University People's Hospital

    Investigators

    • Principal Investigator: Zhanguo Li, Department of Rheumatology and Immunology,Peking University People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT02569463
    Other Study ID Numbers:
    • IL2-MAS
    First Posted:
    Oct 6, 2015
    Last Update Posted:
    Oct 6, 2015
    Last Verified:
    Oct 1, 2015
    Additional relevant MeSH terms:
    Macrophage Activation Syndrome
    Syndrome
    Aldesleukin
    Interleukin-2

    Study Results

    No Results Posted as of Oct 6, 2015