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

Phase 1

• Conditions: Macrophage Activation Syndrome
• Interventions: Drug: Interleukin-2

• Registration Number: NCT02569463
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study Start: 2014-06
• Status Verified: 2015-10
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-04
• Last Update Submitted: 2015-10-04
• Study First Posted: 2015-10-06
• Last Update Posted: 2015-10-06
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-does rhIL-2 therapy	Interleukin-2	Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Rheumatology and Immunology, Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China