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

NCT ID: NCT02569463

Last Updated: 2015-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Macrophage Activation Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Interleukin-2

Intervention Type DRUG

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

Interventions

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Interleukin-2

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

Intervention Type DRUG

Other Intervention Names

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Recombinant Human Interleukin-2

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhanguo Li

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing He, MD

Role: CONTACT

8618611707347

Facility Contacts

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Jing He, MD, PhD

Role: primary

+8618611707347

Other Identifiers

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IL2-MAS

Identifier Type: -

Identifier Source: org_study_id

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