Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117156
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2005-06-30
Brief Title:
Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkins Lymphoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-07
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 the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with mucosa-associated lymphoid tissue MALT lymphoma marginal zone lymphoma MZL or CD5- CD10- CD20 low-grade B cell lymphomas
Detailed Description:
Objectives
Primary
- To estimate the objective response rate
Secondary
To assess the safety
To describe the progression-free survival at one year
To examine the association between clonal cytogenetic abnormalities identified by FISH and the objective response rate as well as the progression-free survival at one year
Target enrollment was 30 eligible patients An 80 objective response rate at 1 month restaging after 6 cycles was considered as evidence of activity in this patient population while 60 was not considered activity If at least 22 patients achieved objective response the treatment would be considered promising With 30 eligible patients the probability of observing this was 087 assuming a true rate of 80 and 009 assuming a true rate of 60
Primary
- To estimate the objective response rate
Secondary
To assess the safety
To describe the progression-free survival at one year
To examine the association between clonal cytogenetic abnormalities identified by FISH and the objective response rate as well as the progression-free survival at one year
Target enrollment was 30 eligible patients An 80 objective response rate at 1 month restaging after 6 cycles was considered as evidence of activity in this patient population while 60 was not considered activity If at least 22 patients achieved objective response the treatment would be considered promising With 30 eligible patients the probability of observing this was 087 assuming a true rate of 80 and 009 assuming a true rate of 60
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