Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005589
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2000-05-02
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkins Lymphoma
Sponsor:
EBMT Solid Tumors Working Party
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Study of Rituximab Mabthera in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy
Status:
COMPLETED
Status Verified Date:
2007-03
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the effects of in vivo rituximab purging and maintenance on progression-free survival in patients with relapsed or resistant follicular non-Hodgkins lymphoma undergoing high-dose chemotherapy
Determine the effects of this regimen on response rate and overall survival in this patient population
Determine the effects of in vivo purging with rituximab on molecular remission rates in the hematopoietic product and the patients
Determine the safety of rituximab in the transplant setting
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to type of remission complete vs good partial and which remission second vs third Patients are randomized to one of four treatment arms
All patients receive induction chemotherapy comprising cyclophosphamide IV over 3-4 hours on day 0 or a standard induction chemotherapy regimen Filgrastim G-CSF is administered subcutaneously daily beginning on day 1
Patients are then randomized to receive either in vivo rituximab purging or no purging following restaging after completion of induction For those patients receiving purging arms I and II rituximab is administered IV once weekly for 4 weeks
Peripheral blood stem cells PBSC are collected between days 8 and 12 post induction chemotherapy Within 4 weeks of PBSC collection patients receive carmustine IV over 2 hours on day -6 etoposide IV over 2 hours on days -5 to -2 cytarabine IV over 5 minutes twice daily on days -5 to -2 and melphalan IV over 10-15 minutes on day -1 Alternatively high dose cyclophosphamide and total body irradiation beginning 2-4 weeks after cyclophosphamide or standard induction chemotherapy priming is also allowed PBSC are reinfused on day 0
Patients are further randomized to receive either rituximab maintenance or observation only For those patients receiving maintenance arms I and III rituximab is administered IV once every 2 months for 4 doses beginning 30 days after PBSC reinfusion
Patients are followed at 30 days 3 6 9 and 12 months after PBSC transplant every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 460 patients 115 per treatment arm will be accrued for this study within 5 years
Determine the effects of in vivo rituximab purging and maintenance on progression-free survival in patients with relapsed or resistant follicular non-Hodgkins lymphoma undergoing high-dose chemotherapy
Determine the effects of this regimen on response rate and overall survival in this patient population
Determine the effects of in vivo purging with rituximab on molecular remission rates in the hematopoietic product and the patients
Determine the safety of rituximab in the transplant setting
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to type of remission complete vs good partial and which remission second vs third Patients are randomized to one of four treatment arms
All patients receive induction chemotherapy comprising cyclophosphamide IV over 3-4 hours on day 0 or a standard induction chemotherapy regimen Filgrastim G-CSF is administered subcutaneously daily beginning on day 1
Patients are then randomized to receive either in vivo rituximab purging or no purging following restaging after completion of induction For those patients receiving purging arms I and II rituximab is administered IV once weekly for 4 weeks
Peripheral blood stem cells PBSC are collected between days 8 and 12 post induction chemotherapy Within 4 weeks of PBSC collection patients receive carmustine IV over 2 hours on day -6 etoposide IV over 2 hours on days -5 to -2 cytarabine IV over 5 minutes twice daily on days -5 to -2 and melphalan IV over 10-15 minutes on day -1 Alternatively high dose cyclophosphamide and total body irradiation beginning 2-4 weeks after cyclophosphamide or standard induction chemotherapy priming is also allowed PBSC are reinfused on day 0
Patients are further randomized to receive either rituximab maintenance or observation only For those patients receiving maintenance arms I and III rituximab is administered IV once every 2 months for 4 doses beginning 30 days after PBSC reinfusion
Patients are followed at 30 days 3 6 9 and 12 months after PBSC transplant every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 460 patients 115 per treatment arm will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-99050 | None | None | None |
| EBMT-EBMTLYM1 | None | None | None |
| BNLI-EBMT-EBMTLYM1 | None | None | None |