Advanced MRI Measures of Repair in Alemtuzumab Treated Patients (iCAMMS-IST)

October 12, 2018 updated by: Anthony Traboulsee, University of British Columbia

Advanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated Patients

There are two parts to this investigator sponsored trial (IST):

  1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.
  2. To provide serum samples for the University of Southern California (USC) ICAM125 lymphocyte recovery study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multiple Sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous System (CNS). There are many forms of MS; although the majority are Relapsing Remitting (RRMS) representing approximately 80% of the cases. The disease appears to be more inflammatory in RRMS as manifested by an increase in Gadolinium (Gd) enhancement on MRI and an increase in inflammatory bio-assay markers.

Alemtuzumab; a humanized monoclonal antibody that targets the CD52 molecule present on T and B lymphocytes, natural killer (NK) cells, and monocytes and macrophages; effects rapid and sustained lymphocyte depletion and is approved for the treatment of B-cell chronic lymphocytic leukemia in many countries under the names CAMPATH or MabCAMPATH.

There are two parts to this Investigator Sponsored Trial (IST):

  1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.
  2. To provide serum samples for the University of Southern California (USC) ICAM125 lymphocyte recovery study.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 3

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • University of British Columbia Hospital

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed, informed consent form
  • Age 18 to 50 years old (inclusive)
  • Diagnosis of MS per update of McDonald criteria, and cranial MRI scan demonstrating white matter lesions attributable to MS within 10 years of screening
  • Onset of MS symptoms within 15 years of screening
  • Neurostatus (EDSS) score 0.0 to 5.0 (inclusive)
  • 2 MS attacks (first episode or relapse) occurring in the 24 months prior to screening, with 1 attack in the 12 months prior to screening, with objective neurological signs confirmed by a physician.

Exclusion Criteria:

  • Received prior therapy for MS other than corticosteroids within 28 days of screening; e.g., interferon's, IV immunoglobulin, and glatiramer acetate
  • Exposure to natalizumab within 6 months of screening
  • Any prior exposure to mitoxantrone, mycophenolate mofetil, azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, rituximab, or any other immunosuppressive agent other than systemic corticosteroid treatment
  • Has any progressive form of MS
  • History of malignancy (exception for basal cell skin carcinoma)
  • Previous hypersensitivity reaction to other immunoglobulin product
  • Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
  • CD4+, CD8+, or CD19+ (i.e., absolute CD3+CD4+, CD3+CD8+, or CD19+/mm3) count <LLN at Screening; if abnormal cell count(s) return to within normal limits, eligibility may be reassessed
  • Seropositivity for human immunodeficiency virus (HIV)
  • Significant autoimmune disease (e.g, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders; vasculitis; inflammatory bowel disease; severe psoriasis)
  • Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies
  • Active infection
  • Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
  • Infection with hepatitis B virus or hepatitis C virus
  • Of childbearing potential with a positive serum pregnancy test
  • Unwilling to agree to use a reliable and acceptable contraceptive method throughout the study period
  • Major psychiatric disorder that is not adequately controlled by treatment
  • Epileptic seizures that are not adequately controlled by treatment
  • Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results
  • Medical, psychiatric, cognitive, or other conditions
  • Confirmed platelet count the lower limit of normal (LLN) of the evaluating laboratory at Screening or documented at 100,000/L within the past year on a sample without clumping
  • Prior history of invasive fungal infections
  • Cervical high risk human papilloma virus (HPV) positivity or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS).
  • Seropositive for Trypanosoma cruzi or the Human T-lymphotropic virus type I or type II (HTLV-I/II) (testing required in endemic regions only)
  • Any other illness or infection (latent or active) that, in the Investigator's opinion, could be exacerbated by alemtuzumab treatment
  • Any hepatic or renal function value grade 2 or higher at Screening, with the exception of hyperbilirubinemia due to Gilbert's syndrome.

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: MabCampath-1h
Single arm, single cohort study, all subjects will be dosed with alemtuzumab.
Drug: MabCampath-1h
Drug:10 mg/mL alemtuzumab intravenous infusion. Form: Sterile, clear, colorless solution. Dosage: 2 cycles. Month 0 dosed over 5 consecutive days; month 12 dosed over 3 consecutive days.
Other Names:
  • Alemtuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in normal appearing white matter from baseline through month 24.
Time Frame: 24 months
The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify specific changes in T cell subsets and functions in Relapsing Remitting Multiple Sclerosis from baseline through month 48.
Time Frame: 48 months
Analyzing changes is immune responsiveness may reveal critical information about the mechanisms by which alemtuzumab acts, confirm the importance of specific immune cell types or molecules as targets for alemtuzumab treatment or may also be useful for monitoring drug effectiveness and safety.
48 months

Collaborators and Investigators

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

Sponsor

University of British Columbia

Collaborators

Genzyme, a Sanofi Company

Investigators

  • Principal Investigator: Anthony Traboulsee, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2011

Primary Completion (Actual)

September 28, 2018

Study Completion (Actual)

September 28, 2018

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (Estimate)

March 2, 2011

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-02482
  • 142402 (Other Identifier: Health Canada - NOL)

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.

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