Assessing the Induction of Long-term Immune Regulation Following Treatment With Lemtrada® (Alemtuzumab).

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Other: Assessment of leukocyte function.

• Registration Number: NCT03647722
• Lead Sponsor: University of Southern California

Brief Summary

In this study the investigators wish to test the hypothesis that treatment with Lemtrada is associated with alterations in immune homeostasis in favor of multiple regulatory leukocyte populations which persist long after completion of the treatment phase. Specifically, the investigators propose that regulatory B-cells are induced rapidly following the first course of treatment with Lemtrada, that this occurs prior to induction of other regulatory populations, and that these cells are functionally capable of regulating immune responses. The investigators also propose that there is a concomitant induction of functional regulatory T-cells and alternatively-activated monocytes during the first year after treatment giving a "blanket" enhanced regulatory immune profile. This study is designed primarily to identify possible mechanisms by which Lemtrada acts to modify the immune environment in recipient patients, as such the "outcome" measures are all immunological.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Study Start: 2018-11-02
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Patient must qualify to receive treatment with Lemtrada according to the USC, Department of Neurology, MS Group Clinical Lemtrada Protocol.
• Patient must have been diagnosed with clinically definite Multiple Sclerosis defined by the revised McDonald criteria (Polman et al., 2005, Polman et al., 2010) of the relapsing-remitting form with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5.
• Patient must have the ability to understand and sign this study-specific IRB-approved informed consent form.
• Patients must be willing to donate 80mls of blood for immunological testing either prior to receiving Lemtrada or 6, 12, 18 or 24 months after first round of treatment.

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Exclusion Criteria

• Patient does not qualify to receive treatment with Lemtrada according to the USC, Department of Neurology, MS Group Clinical Lemtrada Protocol.
• Inability to understand nature of the study.
• Patient has any form of progressive MS.
• Patient has been diagnosed with any other autoimmune disease.
• Patient is of child bearing age with a positive pregnancy test or is unwilling to agree to use a reliable contraceptive method.
• Treatment with any of the following within 30 days of commencing treatment with Lemtrada or collection of baseline blood sample: Gilenya, Aubagio, Tecfidera.
• Treatment with Natalizumab within 60 days of commencing treatment with Lemtrada or collection of baseline blood sample.
• Treatment with any of the following within 6 months of commencing treatment with Lemtrada or collection of baseline blood sample: Rituximab, Ocrevus.
• Treatment at any time with any of the following: Mitoxantrone, Cyclophosphamide, Cladribine, Cyclosporine, Azathioprine, Methotrexate or any other immunomodulatory, immunosuppressant or immune homeostasis altering drug.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lemtrada treated - 18 month	Assessment of leukocyte function.	Patients that received their first course of treatment with Lemtrada approximately 18 months prior and their second course of treatment with Lemtrada approximately 6 months prior.
Lemtrada treated - 24 month	Assessment of leukocyte function.	Patients that received their first course of treatment with Lemtrada approximately 24 months prior and their second course of treatment with Lemtrada approximately 18 months prior and who have not received any further treatment.
Lemtrada treated - 12 month	Assessment of leukocyte function.	Patients that received their first course of treatment with Lemtrada approximately 12 months prior but who have not received the second course of treatment.
Lemtrada treated - 6 month	Assessment of leukocyte function.	Patients that received their first course of treatment with Lemtrada approximately 6 months prior.
Lemtrada qualified - untreated	Assessment of leukocyte function.	Patients that are qualified to start treatment with Lemtrada but have not yet being untreated.

Primary Outcome Measures

Name	Time	Method
Assess changes in the circulating regulatory B-cell population.	12 months

Trial Locations

Locations (1)

University of Southern California, Department of Neurology; 🇺🇸 Los Angeles, California, United States