Lymphocyte depletion in cladribine treated PwMS
Research type
Research Study
Full title
Effect of deoxycytidine kinase (dCK), adenosine deaminase (ADA) and 5'-nucleotidase (5'-NT) on lymphocyte depletion in cladribine treated multiple patients with sclerosis
IRAS ID
272328
Contact name
Daniel Belete
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
Multiple sclerosis (MS) is an autoimmune condition that causes demyelination and damage to nerve cells in the central nervous system. Most patients with MS (PwMS) will experience a clinical syndrome characterised by relapses and remissions (RRMS). Recurrent relapses lead to the progressive accumulation of disability, with worsening recovery between episodes. It is therefore of therapeutic importance to try and prevent relapses. Relapses are thought to be mediated by the inflammatory mechanisms of lymphocytes, which lead to the demyelination of neurons.
Cladribine is a medication that causes immunosuppression. It causes peripheral depletion of lymphocytes. Subsequently, over several months, peripheral lymphocyte counts regenerate. This is thought to reset the immune system and reduce rates of relapses in RRMS.
A small group of patients treated with cladribine do not have a reduction in their lymphocyte count and therefore may not receive the intended therapeutic benefits. The reasons behind this are not understood. Previous studies suggest that the ratios of dCK, ADA and 5’-NT could all play a role in the efficacy of cladribine. This study will aim to understand how intracellular lymphocyte levels of dCK, ADA and 5’-NT effect lymphocyte depletion in cladribine treated PwMS. Understanding this could help clinicians better select patients that would receive benefit from cladribine therapy and consider dose adjustment.
Cladribine treated PwMS would be eligible to enroll in the study. Recruitment of participants into the study will happen in the neurology outpatients department of the Royal London Hospital. Analysis of blood samples will happen in the Blizard Institute. The study will last 11 months. Participants will undergo a blood test. The study will not affect or influence patient treatment in any way.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
19/WM/0329
Date of REC Opinion
30 Oct 2019
REC opinion
Favourable Opinion