Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119730
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2005-07-07
Brief Title:
Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Abbreviated Fludarabine Mitoxantrone Rituximab Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2014-04
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 find out whether combining a short course of chemotherapy Fludarabine Mitoxantrone and Rituximab followed by Zevalin will be effective in treating relapsed mantle cell lymphoma
The secondary purposes of the study are to determine the safety and to evaluate whether there is additional benefit from Zevalin therapy following the chemotherapy
The secondary purposes of the study are to determine the safety and to evaluate whether there is additional benefit from Zevalin therapy following the chemotherapy
Detailed Description:
Patients receive fludarabine days 1-3 mitoxantrone day 1 and rituximab day 1 of each 28-day cycle
Patients undergo a CT scan and bone marrow biopsy after two cycles Unless the cancer has progressed the patient will then receive Zevalin study treatment
Blood counts are taken every week for 12 weeks After 12 weeks a CT scan and bone marrow biopsy are performed
Long-term followup is 4 years Physical exam and blood work is performed every 3 months for the first two years Following that physical exams and blood work is every 6 months for another two years CT scans and bone marrow biopsies are every 6 months during this 4 year followup period
Patients undergo a CT scan and bone marrow biopsy after two cycles Unless the cancer has progressed the patient will then receive Zevalin study treatment
Blood counts are taken every week for 12 weeks After 12 weeks a CT scan and bone marrow biopsy are performed
Long-term followup is 4 years Physical exam and blood work is performed every 3 months for the first two years Following that physical exams and blood work is every 6 months for another two years CT scans and bone marrow biopsies are every 6 months during this 4 year followup period
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