Increasing T-regulatory cells after alemtuzumab or cladribine treatment in people with multiple sclerosis

Not Applicable

Completed

• Conditions: Immune system recovery (reconstitution) after lymphocyte-depleting therapies in multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN17601680
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-31
• Study Completion: 2023-12-01
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Able to provide informed consent
2. Definite diagnosis of relapsing-remitting multiple sclerosis
3. Treated with alemtuzumab or cladribine within a specified period before recruitment

Exclusion Criteria

1. Concurrent treatment with Copaxone, beta interferon, dimethyl fumarate, teriflunomide, fingolimod, natalizumab or ocrelizumab
2. Concurrent use of any other immunosuppressant or cytotoxic therapy
3. Oral/IV high-dose steroid use within 4 weeks of recruitment to the study
4. Participants who have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the screening assessment, or are currently enrolled in an interventional investigational trial
5. Any planned vaccination in the 4 weeks preceding screening, or at any point during the study
6. Hypersensitivity to Proleukin or any of its excipients
7. History of severe cardiac disease
8. History of malignancy 5 years prior to screening (except adequately treated cervical carcinoma in situ, or basal and squamous cell skin carcinoma)
9. Clinically significant renal, hepatic, or haematological abnormalities as defined in the study protocol
10. Evidence of an active infection. Participants may be recruited a minimum of 48 hours after the resolution of illness or completion of antibacterial/antiviral therapy
11. Pregnant or breastfeeding women; or male and female participants who do not agree to use a highly effective method of contraception during the study
12. Any other factor deemed potentially relevant by the research team

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the frequency of T-regulatory cells in blood after interleukin-2 treatment in participants who have previously received alemtuzumab, measured using flow cytometry; the change in frequency is calculated between baseline (pre-intervention) and after completing the intervention (2-4 days after final interleukin-2 dose)

Secondary Outcome Measures

Name	Time	Method
There are no planned secondary outcomes. <br>All additional outcomes are exploratory, and can include, but are not limited to:<br>1. Phenotypic changes e.g. (naïve:memory T-effector ratio, NK cell frequency; T-reg deep immunophenotyping) of lymphocytes in blood measured using flow cytometry at baseline (pre-intervention) and 2-4 days after the final interleukin-2 dose <br>2. Change in the frequency of T-regulatory cells after interleukin-2 in the blood of participants who had previously received cladribine, measured using flow cytometry at baseline (pre-intervention) and 2-4 days after the final interleukin-2 dose