Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136396
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2005-08-26
Brief Title:
Rituximab Therapy for Steroid-Refractory Chronic Graft Versus Host Disease
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
An Open Label Phase III Trial of Rituximab Therapy for Steroid-Refractory Chronic Graft vs Host Disease
Status:
COMPLETED
Status Verified Date:
2013-06
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:
The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease GVHD
Detailed Description:
Patients will receive rituximab intravenously one time per week for four consecutive weeks Once therapy is completed the patient will have weekly visits with their physician for four more weeks at which they will complete a simple questionnaire designed to evaluate the severity of chronic graft versus host disease
At the end of the eighth week on the study 4 weeks of study treatment and 4 weeks of observation patients will be evaluated to determine whether their chronic graft versus host disease GVHD has resolved
If chronic graft versus host disease has resolved entirely the patient will be monitored for the remainder of the year
If after the initial eight weeks on the study the patient still has symptoms or signs of GVHD they may receive a second four week study treatment
If the patients chronic GVHD reappears after receiving either one or two courses of rituximab a third and final four week course of medication can be given provided it has been at least eight weeks since the last dose
Blood tests will be performed at the beginning of the study after 8 weeks on the study after 16 weeks on the study and at the end of 1 year
At the end of the eighth week on the study 4 weeks of study treatment and 4 weeks of observation patients will be evaluated to determine whether their chronic graft versus host disease GVHD has resolved
If chronic graft versus host disease has resolved entirely the patient will be monitored for the remainder of the year
If after the initial eight weeks on the study the patient still has symptoms or signs of GVHD they may receive a second four week study treatment
If the patients chronic GVHD reappears after receiving either one or two courses of rituximab a third and final four week course of medication can be given provided it has been at least eight weeks since the last dose
Blood tests will be performed at the beginning of the study after 8 weeks on the study after 16 weeks on the study and at the end of 1 year
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