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

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ClinicalTrials.gov Identifier: NCT03647722
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Brett T. Lund, 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Assessment of leukocyte function.

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessing the Induction of Long-term Immune Regulation Following Treatment With Lemtrada® (Alemtuzumab).
Actual Study Start Date : November 2, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab

Group/Cohort Intervention/treatment
Lemtrada treated - 6 month
Patients that received their first course of treatment with Lemtrada approximately 6 months prior.
Other: Assessment of leukocyte function.
The function and phenotype of regulatory B-cells, regulatory T-cells and alternatively-activated monocytes will be assessed directly ex vivo from PBMC.

Lemtrada treated - 12 month
Patients that received their first course of treatment with Lemtrada approximately 12 months prior but who have not received the second course of treatment.
Other: Assessment of leukocyte function.
The function and phenotype of regulatory B-cells, regulatory T-cells and alternatively-activated monocytes will be assessed directly ex vivo from PBMC.

Lemtrada treated - 18 month
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.
Other: Assessment of leukocyte function.
The function and phenotype of regulatory B-cells, regulatory T-cells and alternatively-activated monocytes will be assessed directly ex vivo from PBMC.

Lemtrada treated - 24 month
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.
Other: Assessment of leukocyte function.
The function and phenotype of regulatory B-cells, regulatory T-cells and alternatively-activated monocytes will be assessed directly ex vivo from PBMC.

Lemtrada qualified - untreated
Patients that are qualified to start treatment with Lemtrada but have not yet being untreated.
Other: Assessment of leukocyte function.
The function and phenotype of regulatory B-cells, regulatory T-cells and alternatively-activated monocytes will be assessed directly ex vivo from PBMC.




Primary Outcome Measures :
  1. Assess changes in the circulating regulatory B-cell population. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will recruit 125 individuals with clinically definite MS, defined by the revised McDonald criteria (35). Patients in each cohort will be enrolled from those currently being seen by physicians at the University of Southern California, Department of Neurology.
Criteria

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.

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.

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): NCT03647722


Contacts
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Contact: Brett T Lund, Ph.D. 323-442-3079 blund@usc.edu

Locations
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United States, California
University of Southern California, Department of Neurology Recruiting
Los Angeles, California, United States, 90033
Contact: Brett T Lund, Ph.D.    323-442-3079    blund@usc.edu   
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Brett T Lund, Ph.D. University of Southern California

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Responsible Party: Brett T. Lund, Assistant Professor, Neurology, University of Southern California
ClinicalTrials.gov Identifier: NCT03647722     History of Changes
Other Study ID Numbers: LemRegUSC
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Alemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents