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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02569463

Enrollment

Registered

2015-10-06

Start date

2014-06-30

Completion date

2018-06-30

Last updated

2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macrophage Activation Syndrome

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.

Interventions

DRUGInterleukin-2

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactJing He, MD

hejing1105@126.com8618611707347

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026