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

Last updated: October 4, 2015
Sponsor: Peking University People's Hospital
Overall Status: Trial Status Unknown

Phase

1/2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02569463
IL2-MAS
  • Ages 16-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 6
Study Start date:
June 01, 2014
Estimated Completion Date:
June 30, 2018

Study 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.

Connect with a study center

  • Department of Rheumatology and Immunology, Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

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