Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280878
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2006-01-22
Brief Title:
Rituximab in Combination With Outpatient Therapy for CD20 Lymphoma
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
A Pilot Study of Rituximab in Combination With Out-patient Based VGFF-GIV Salvage Therapies for RelapsedRefractory CD20 Lymphomas
Status:
COMPLETED
Status Verified Date:
2007-10
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 is a Phase II pilot study evaluating the safety of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF vinorelbine gemcitabine and pegfilgrastim andor F-GIV gemcitabine Ifosfamide vinorelbine and pegfilgrastim in combination with Rituximab R-VGFR-F-GIV
Detailed Description:
Recent epidemiologic surveys have demonstrated a dramatic increase in the incidence of non-Hodgkins lymphoma NHL NHL is now one of the most rapidly increasing malignancies in the industrial world
The purpose of this project is to evaluate the efficacy and safety of an outpatient treatment for relapsed or treatment resistant refractory CD20 lymphoma Two combinations of chemotherapy drugs will be tested depending on the patients prior therapy and response - rituximab vinorelbine and gemcitabine R-VGF OR rituximab vinorelbine gemcitabine and ifosfamide R-FGIV
Previous experience including a recently completed study using combinations of vinorelbine gemcitabine and ifosfamide has demonstrated that such an outpatient approach is safe and of similar efficacy to presently available alternative inpatient chemotherapy approaches This study is expanding on the findings from the previous study by adding rituximab
Rituximab is being increasingly and successfully used in the therapy of CD20 NHL It is a specific protein antibody that is directed against the surface protein CD20 antigen found on CD20 lymphoma cells and can therefore lead to the destruction of these cells Rituximab also has a highly favourable toxicity profile enabling outpatient treatment
All of these factors provide a strong rationale for the combination of rituximab and the novel outpatient-based salvage approaches VGF and F-GIV that we have recently evaluated This pilot study of 12 patients will test the feasibility of this combination approach in patients with relapsedrefractory CD20 NHL
The purpose of this project is to evaluate the efficacy and safety of an outpatient treatment for relapsed or treatment resistant refractory CD20 lymphoma Two combinations of chemotherapy drugs will be tested depending on the patients prior therapy and response - rituximab vinorelbine and gemcitabine R-VGF OR rituximab vinorelbine gemcitabine and ifosfamide R-FGIV
Previous experience including a recently completed study using combinations of vinorelbine gemcitabine and ifosfamide has demonstrated that such an outpatient approach is safe and of similar efficacy to presently available alternative inpatient chemotherapy approaches This study is expanding on the findings from the previous study by adding rituximab
Rituximab is being increasingly and successfully used in the therapy of CD20 NHL It is a specific protein antibody that is directed against the surface protein CD20 antigen found on CD20 lymphoma cells and can therefore lead to the destruction of these cells Rituximab also has a highly favourable toxicity profile enabling outpatient treatment
All of these factors provide a strong rationale for the combination of rituximab and the novel outpatient-based salvage approaches VGF and F-GIV that we have recently evaluated This pilot study of 12 patients will test the feasibility of this combination approach in patients with relapsedrefractory CD20 NHL
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