Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415864
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-04-03
Brief Title:
Oral Cladribine B-cell Study
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
Oral Cladribine B-cell Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study the impact of cladribine on peripheral and intrathecal B-cell plasma cells T cells and Tregs
Detailed Description:
Primary To quantify the temporal changes of memory B cells CD19CD27IgD- plasmablasts CD19-CD138CD38 and T cells CD4CD45RA- CCR7- CD8CD45RA-CCR7- Tregs CD4CD8CD25CD127-Fox3 P in the peripheral venous blood of pwMS with RRMS over 96w of treatment with oral cladribine
These will be compared to the populations of non-memory or class-switched B cells immaturetransitional B cells CD10CD38CD19 immature regulatory B cells CD10CD38CD19CD24IL-10 mature B cells CD10-CD38CD19
Secondary
1 To study the effects of oral cladribine on
1 CSF OCBs and free immunoglobulin kappa and lambda light chain levels FLC
2 CSF markers of inflammation in particular CXCL-13 and urine markers of inflammation neopterin
3 CSF markers of neuroaxonal damage in particular free neurofilament light chains
4 On the peripheral repertoire B-cells immunoglobulin and T-cells T cell receptor and plasma cells soluble receptors
2 To compare CSF OCB positivity and CSF light chain levels with a contemporary control group of alemtuzumab treated pwMS historical data
Tertiary
1 To compare B and T cell repertoire with a contemporary control group of alemtuzumab treated pwMS historical data
2 To evaluate the effect of changes in the immune cell profile on clinical measures of disability MRI activity and PROMS
These will be compared to the populations of non-memory or class-switched B cells immaturetransitional B cells CD10CD38CD19 immature regulatory B cells CD10CD38CD19CD24IL-10 mature B cells CD10-CD38CD19
Secondary
1 To study the effects of oral cladribine on
1 CSF OCBs and free immunoglobulin kappa and lambda light chain levels FLC
2 CSF markers of inflammation in particular CXCL-13 and urine markers of inflammation neopterin
3 CSF markers of neuroaxonal damage in particular free neurofilament light chains
4 On the peripheral repertoire B-cells immunoglobulin and T-cells T cell receptor and plasma cells soluble receptors
2 To compare CSF OCB positivity and CSF light chain levels with a contemporary control group of alemtuzumab treated pwMS historical data
Tertiary
1 To compare B and T cell repertoire with a contemporary control group of alemtuzumab treated pwMS historical data
2 To evaluate the effect of changes in the immune cell profile on clinical measures of disability MRI activity and PROMS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None