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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569463
Recruitment Status : Unknown
Verified October 2015 by Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : October 6, 2015
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Macrophage Activation Syndrome Drug: Interleukin-2 Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficiency Study of Low-dose IL-2 Treatment in Macrophage Activation Syndrome
Study Start Date : June 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aldesleukin

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 Name: Recombinant Human Interleukin-2




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569463


Contacts
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Contact: Jing He, MD 8618611707347 hejing1105@126.com

Locations
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China, Beijing
Department of Rheumatology and Immunology, Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Jing He, MD, PhD    +8618611707347    hejing1105@126.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Zhanguo Li Department of Rheumatology and Immunology,Peking University People's Hospital

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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02569463     History of Changes
Other Study ID Numbers: IL2-MAS
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Macrophage Activation Syndrome
Syndrome
Disease
Pathologic Processes
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Aldesleukin
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents