Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169195
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2005-09-12
Brief Title:
Rituximab Gemcitabine and Oxaliplatin R-GEMOX for RefractoryRelapsed B-cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Gemcitabine-oxaliplatin Plus Rituximab R-GEMOX in RefractoryRelapsed Patients With CD 20 Positive Diffuse Large B-cell Lymphoma Non Eligible for High-dose Chemotherapy Followed by Autotransplantation
Status:
COMPLETED
Status Verified Date:
2015-09
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 evaluate the efficacy and the safety of R-GEMOX in refractoryrelapsed patients with CD20-positive large B-cell lymphoma who are not eligible for autologous transplantation
Detailed Description:
This is a multicentric open-label non-randomized clinical study evaluating the efficacy and the safety of R-GEMOX in refractoryrelapsed patients aged from 18 to 75 years with CD20-positive large B-cell lymphoma non eligible for autologous transplantation
It is anticipated that 50 subjects will be enrolled over 4 years from April 2003January 2007 but inclusion could stop earlier according to the analysis performed every 5 patients based on triangular test
The duration of the treatment period is approximately 16 weeks and patients are followed until death
The total duration of the study is expected to be 3 years
It is anticipated that 50 subjects will be enrolled over 4 years from April 2003January 2007 but inclusion could stop earlier according to the analysis performed every 5 patients based on triangular test
The duration of the treatment period is approximately 16 weeks and patients are followed until death
The total duration of the study is expected to be 3 years
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