Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324467
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2006-05-09
Brief Title:
Tailoring Treatment for B Cell Non-hodgkins Lymphoma Based on PET Scan Results Mid Treatment
Sponsor:
British Columbia Cancer Agency
Organization:
British Columbia Cancer Agency
Study Overview
Official Title:
Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkins Lymphoma Based on Mid-Treatment Positron Emission Tomography PET Scan Results
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
LYTPET
Brief Summary:
The purpose of this study is to assess whether patients who are likely to fail R-CHOP as predicted by a mid-treatment PET scan can have an improved outcome if switched to a standard salvage regimen R-ICE rituximab ifosfamide carboplatin etoposide
Patients who have a negative PET scan after 4 cycles of R-CHOP have an excellent prognosis 85 chance of cure and should complete treatment with 6 cycles of standard R-CHOP Patients who have a positive PET scan after 4 cycles of R-CHOP have a very poor prognosis 10 chance of cure and may have an improved outcome if switched to a non-cross resistant chemotherapy combination R-ICE
Patients who have a negative PET scan after 4 cycles of R-CHOP have an excellent prognosis 85 chance of cure and should complete treatment with 6 cycles of standard R-CHOP Patients who have a positive PET scan after 4 cycles of R-CHOP have a very poor prognosis 10 chance of cure and may have an improved outcome if switched to a non-cross resistant chemotherapy combination R-ICE
Detailed Description:
This is a phase II trial investigating tailoring first-line therapy for advanced stage diffuse large B-cell NHL DLBCL based on a mid-treatment 18F-FDG- positron-emission tomography PET scan result More than half of all patients with DLBCL can be cured with 6-8 cycles of standard R-CHOP rituximab cyclophosphamide doxorubicin vincristine prednisone Patients who are not cured with R-CHOP have a very poor prognosis This study will assess whether patients who are likely to fail R-CHOP as predicted by a mid-treatment PET scan can have an improved outcome if switched to a standard salvage regimen R-ICE rituximab ifosfamide carboplatin etoposide
Objectives
To assess the efficacy of tailoring first-line therapy based on a mid- treatment PET scan result for patients with advanced stage DLBCL
To assess the progression-free survival PFS in patients with advanced stage DLBCL who have a negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R followed by four cycles of R-ICE chemotherapy
To assess the overall survival OS in patients with advanced stage DLBCL who have a negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R followed by four cycles of R-ICE chemotherapy
Objectives
To assess the efficacy of tailoring first-line therapy based on a mid- treatment PET scan result for patients with advanced stage DLBCL
To assess the progression-free survival PFS in patients with advanced stage DLBCL who have a negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R followed by four cycles of R-ICE chemotherapy
To assess the overall survival OS in patients with advanced stage DLBCL who have a negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R followed by four cycles of R-ICE chemotherapy
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