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
- First listed
- May 16, 2024
- 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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