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

Macrophage Activation Syndrome Clinical Trial

Official title:

Safety and Efficiency Study of Low-dose IL-2 Treatment in Macrophage Activation Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02569463
• Other study ID #: IL2-MAS
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 2, 2015
• Last updated: October 4, 2015
• Start date: June 2014
• Est. completion date: June 2018

Study information

• Verified date: October 2015
• Source: Peking University People's Hospital
• Contact: Jing He, MD
• Phone: 8618611707347
• Email: hejing1105[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macrophage Activation Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	Department of Rheumatology and Immunology, Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1month	Yes