Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00143871
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2005-08-31
Brief Title:
Study of Rituximab Plus High-Dose Chemotherapy Non-Hodgkins Lymphoma
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Rituximab Plus High-dose Chemotherapy With Autologous Stem Cell Support for Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-01
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:
This study is being conducted to determine the safety side effects and response to a combination of an established high-dose chemotherapy regimen plus the addition of Rituximab which is a form of immunotherapy
Detailed Description:
Combination chemotherapy is the standard treatment as initial therapy for advanced stage aggressive Non-Hodgkins lymphoma NHL Standard chemotherapy cures less than 40 of patients When patients relapse they may be eligible to receive high-dose chemotherapy with autologous stem cell support Multiple studies have shown the value of high-dose chemotherapy with increased disease-free survival and overall survival when compared with second-line conventional chemotherapy Unfortunately high-dose chemotherapy is curative in less than half the patients who receive it and other treatment strategies are needed to improve the cure rate
Another treatment option called immunotherapy is being tested in lymphoma patients Immunotherapy involves attempts to use the immune system or products of the immune system to fight lymphoma For example NHL cells have a protein called CD20 on their surface Rituximab is an antibody directed against the CD20 protein which may result in the death of the lymphoma cell Patients in this study will receive Rituximab to see if it is a safe treatment option for NHL patients
Another treatment option called immunotherapy is being tested in lymphoma patients Immunotherapy involves attempts to use the immune system or products of the immune system to fight lymphoma For example NHL cells have a protein called CD20 on their surface Rituximab is an antibody directed against the CD20 protein which may result in the death of the lymphoma cell Patients in this study will receive Rituximab to see if it is a safe treatment option for NHL patients
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