Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01042509
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2010-01-04
Brief Title:
Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease
Sponsor:
Hospital Universitario Dr Jose E Gonzalez
Organization:
Hospital Universitario Dr Jose E Gonzalez
Study Overview
Official Title:
Combination of Alemtuzumab Anti-CD52 and Rituximab Anti-CD20 at Low-doses in Chronic Graft Versus Host Disease Treatment After First-line Therapy Failure
Status:
COMPLETED
Status Verified Date:
2016-12
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:
LowAR
Brief Summary:
The purpose of this study is to determine whether low-doses alemtuzumab and rituximab combination are effective in the treatment of chronic graft-versus-host disease GVHD after first-line therapy failure
Detailed Description:
Graft-versus-host disease GVHD is the most common long-term complication in patients who underwent allogeneic transplantation First-line therapy for chronic GVHD is based on immunosuppressive agents usually cyclosporine and corticosteroids achieving satisfactory response in around 30 of patients There is no ideal second-line treatment for chronic GVHD however numerous studies have been published with therapeutic options such as alemtuzumab anti-CD52 and rituximab anti-CD20
This is a prospective longitudinal nonrandomized study in which alemtuzumab and rituximab will be administered at low-doses to patients with refractory chronic GVHD Clinical response will be evaluated based on the Working Group Report 2006 published by the National Institute of Health Consensus Follow-up sessions will be weekly for four weeks every two weeks until achieve response and finally every four weeks
This is a prospective longitudinal nonrandomized study in which alemtuzumab and rituximab will be administered at low-doses to patients with refractory chronic GVHD Clinical response will be evaluated based on the Working Group Report 2006 published by the National Institute of Health Consensus Follow-up sessions will be weekly for four weeks every two weeks until achieve response and finally every four weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None