Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163761
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2005-09-11
Brief Title:
Efficacy Study of Outpatient Therapy for Lymphoma
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-01
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 is a Phase II trial evaluating the efficacy overall response rate of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine gemcitabine and pegfilgrastim andor gemcitabine ifosfamide vinorelbine and pegfilgrastim
Detailed Description:
Lymphoma has been increasing in incidence annually for the past several decades and the majority of patients relapse after first line therapy A variety of salvage chemotherapy treatments are available that are usually inpatient-based treatments associated with significant haematological toxicity Furthermore all patients are treated in the same manner despite the fact that some patients will do well irrespective of the type of salvage therapy whereas others will do badly no matter what is done During 2001-2002 we undertook a pilot study in 40 such patients using an outpatient-based salvage therapy with 2 newer chemotherapy drugs vinorelbine and gemcitabine Over 75 of all treatments were successfully delivered on an outpatient basis with response rates similar to historical controls We now propose to expand on these initial findings by modifying the outpatient approach for those patients with less favourable prognostic features that is patients will be stratified to differing therapies but with the majority still receiving the proven vinorelbine-gemcitabine combination
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