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

October 4, 2015 updated by: Peking University People's Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Department of Rheumatology and Immunology, Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity on the HScore (a Score for the Diagnosis of Reactive Hemophagocytic Syndrome)
Time Frame: 1month
Examination of the therapeutic effects (improvement in HScore) of low dose IL-2 in patients with MAS
1month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 4, 2015

First Posted (Estimate)

October 6, 2015

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 4, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL2-MAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Macrophage Activation Syndrome

Clinical Trials on Interleukin-2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe