Oral Cladribine B-cell Study

Sponsor
Queen Mary University of London
Study ID
NCT06415864
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

To study the impact of cladribine on peripheral and intrathecal B-cell, plasma cells, T cells and Tregs

Key Dates

Start date
Jul 1, 2019
Status verified
Feb 2026
Primary completion
Jan 31, 2024
Completion
Jan 31, 2024

Study Design

Enrollment
10 participants (actual)

Arms

  • Arm: Cladribine (Mavenclad, Merck Serono Ltd)
    In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight

Primary Outcome Measure

Percent Change in Class-switched Memory B Cells From Baseline to Week 96 nh [ Time Frame: Baseline to week 96 ]

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