Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052923
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2003-01-24
Brief Title:
Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive B-Cell Diffuse Large Cell Lymphoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase III Trial Of Rituximab NSC 687451 And Autologous Stem Cell Transplantation For B Cell Diffuse Large Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells It is not yet known whether stem cell transplantation is more effective with or without rituximab in treating relapsed or progressive B-cell diffuse large cell lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of stem cell transplantation with or without rituximab in treating patients who have relapsed or progressive B-cell diffuse large cell lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of stem cell transplantation with or without rituximab in treating patients who have relapsed or progressive B-cell diffuse large cell lymphoma
Detailed Description:
OBJECTIVES
Compare disease-free survival of patients with relapsed or progressive B-cell diffuse large cell lymphoma undergoing stem cell transplantation with or without post-transplant rituximab
Evaluate the effect of rituximab administered post-transplant on the procedure-related mortality of these patients
Determine the potential infectious complications of the addition of this drug to autologous stem cell transplantation in these patients
Compare overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to relapse relapsed more than 6 months after either initial complete remission CR or CR with positive positron emission tomography or MRI gallium vs failed to achieve initial CR or relapsed within 6 months after either initial CR or CR with positive PET or MRI gallium and prior rituximab yes vs no
Stem cell mobilization
Patients receive rituximab IV over 4-8 hours on days 1 and 5 Patients also receive cyclophosphamide IV over 2 hours on day 8 and filgrastim G-CSF subcutaneously SC beginning on day 9 and continuing until the last day of apheresis Stem cells are collected over 1-3 days
Preparative regimen
Regimen A patients who have received prior radiotherapy or are 61 years of age Patients receive carmustine IV over 2 hours on day -6 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2
Regimen B all other patients Patients undergo total body irradiation twice daily on days -8 to -5 Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2
Stem cells are reinfused on day 0 Patients are then randomized to one of two post-transplant treatment arms
Post-transplant treatment
Arm I rituximab Patients receive G-CSF SC beginning on day 6 and continuing until blood counts recover Patients receive rituximab IV over 4-8 hours every 7 days for 4 doses starting on day 45 post-transplant Course of rituximab is repeated beginning on day 180 post-transplant
Arm II no rituximab Patients receive G-CSF as in arm I Patients are followed for 10 years
PROJECTED ACCRUAL A total of 427 patients will be accrued for this study within 35 years
Compare disease-free survival of patients with relapsed or progressive B-cell diffuse large cell lymphoma undergoing stem cell transplantation with or without post-transplant rituximab
Evaluate the effect of rituximab administered post-transplant on the procedure-related mortality of these patients
Determine the potential infectious complications of the addition of this drug to autologous stem cell transplantation in these patients
Compare overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to relapse relapsed more than 6 months after either initial complete remission CR or CR with positive positron emission tomography or MRI gallium vs failed to achieve initial CR or relapsed within 6 months after either initial CR or CR with positive PET or MRI gallium and prior rituximab yes vs no
Stem cell mobilization
Patients receive rituximab IV over 4-8 hours on days 1 and 5 Patients also receive cyclophosphamide IV over 2 hours on day 8 and filgrastim G-CSF subcutaneously SC beginning on day 9 and continuing until the last day of apheresis Stem cells are collected over 1-3 days
Preparative regimen
Regimen A patients who have received prior radiotherapy or are 61 years of age Patients receive carmustine IV over 2 hours on day -6 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2
Regimen B all other patients Patients undergo total body irradiation twice daily on days -8 to -5 Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2
Stem cells are reinfused on day 0 Patients are then randomized to one of two post-transplant treatment arms
Post-transplant treatment
Arm I rituximab Patients receive G-CSF SC beginning on day 6 and continuing until blood counts recover Patients receive rituximab IV over 4-8 hours every 7 days for 4 doses starting on day 45 post-transplant Course of rituximab is repeated beginning on day 180 post-transplant
Arm II no rituximab Patients receive G-CSF as in arm I Patients are followed for 10 years
PROJECTED ACCRUAL A total of 427 patients will be accrued for this study within 35 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CALGB-E2499 | None | None | None |
| ECOG-E2499 | None | None | None |
| CALGB-50205 | None | None | None |