Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012051
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2001-03-03
Brief Title:
Chemotherapy and Peripheral Stem Cell Transplant With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Commissie Voor Klinisch Toegepast Onderzoek
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Phase III Study On The Effect Of The Chimeric Anti-CD20 Monoclonal Antibody Mabthera During Sequential Chemotherapy Followed By Autologous Stem Cell Transplantation In Patients With Relapse B-Cell Non-Hodgkin LymphomaHOVON 44 STUDY
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 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Peripheral stem cell transplant may be able to replace immune cells that were destroyed by the chemotherapy Monoclonal antibodies such as rituximab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them It is not yet known if giving more than one drug combination chemotherapy plus peripheral stem cell transplant is more effective with or without monoclonal antibody therapy in treating non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying how well chemotherapy plus peripheral stem cell transplant with or without monoclonal antibody therapy works in treating patients with relapsed non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying how well chemotherapy plus peripheral stem cell transplant with or without monoclonal antibody therapy works in treating patients with relapsed non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the partial and complete response rates in patients with relapsed CD20 positive aggressive B-cell non-Hodgkins lymphoma treated with dexamethasone cisplatin and cytarabine in combination with etoposide ifosfamide and methotrexate with or without rituximab followed by carmustine etoposide cytarabine melphalan and autologous peripheral blood stem cell transplantation APBSCT
Compare the effect of APBSCT with or without rituximab on the overall and event-free survival of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to one of two treatment arms
Arm I Patients receive DHAP induction chemotherapy comprising dexamethasone orally or IV on days 1-4 cisplatin IV continuously over 24 hours on day 1 and cytarabine IV over 3 hours every 12 hours on day 2 Beginning 3-4 weeks after DHAP patients receive VIM induction chemotherapy comprising etoposide IV over 2 hours on days 1 3 and 5 ifosfamide IV over 1 hour on days 1-5 and methotrexate IV on days 1 and 5 Beginning 3-4 weeks after VIM patients with partial or complete response after DHAP and VIM receive a second course of DHAP patients with progressive or unresponsive disease after DHAP but responsive disease after VIM receive a second course of VIM followed by filgrastim G-CSF subcutaneously beginning on day 10 and continuing until a target number of cells are collected
Arm II Patients receive induction chemotherapy and G-CSF as in arm I At 1 day after the last dose of each chemotherapy course patients also receive rituximab IV once for a maximum of 3 courses
At 4-5 weeks after the completion of the last induction chemotherapy course responsive patients in both arms receive BEAM conditioning chemotherapy comprising carmustine IV over 60 minutes on day -6 etoposide IV over 60 minutes and cytarabine IV over 30 minutes on days -5 to -2 and melphalan IV over 15 minutes on day -1 Patients undergo autologous peripheral blood stem cell transplantation on day 0 After transplantation patients in partial remission may undergo radiotherapy to nodal sites with residual tumor mass
Patients are followed every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 296-340 patients 148-170 per treatment arm will be accrued for this study within 4-5 years
Compare the partial and complete response rates in patients with relapsed CD20 positive aggressive B-cell non-Hodgkins lymphoma treated with dexamethasone cisplatin and cytarabine in combination with etoposide ifosfamide and methotrexate with or without rituximab followed by carmustine etoposide cytarabine melphalan and autologous peripheral blood stem cell transplantation APBSCT
Compare the effect of APBSCT with or without rituximab on the overall and event-free survival of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to one of two treatment arms
Arm I Patients receive DHAP induction chemotherapy comprising dexamethasone orally or IV on days 1-4 cisplatin IV continuously over 24 hours on day 1 and cytarabine IV over 3 hours every 12 hours on day 2 Beginning 3-4 weeks after DHAP patients receive VIM induction chemotherapy comprising etoposide IV over 2 hours on days 1 3 and 5 ifosfamide IV over 1 hour on days 1-5 and methotrexate IV on days 1 and 5 Beginning 3-4 weeks after VIM patients with partial or complete response after DHAP and VIM receive a second course of DHAP patients with progressive or unresponsive disease after DHAP but responsive disease after VIM receive a second course of VIM followed by filgrastim G-CSF subcutaneously beginning on day 10 and continuing until a target number of cells are collected
Arm II Patients receive induction chemotherapy and G-CSF as in arm I At 1 day after the last dose of each chemotherapy course patients also receive rituximab IV once for a maximum of 3 courses
At 4-5 weeks after the completion of the last induction chemotherapy course responsive patients in both arms receive BEAM conditioning chemotherapy comprising carmustine IV over 60 minutes on day -6 etoposide IV over 60 minutes and cytarabine IV over 30 minutes on days -5 to -2 and melphalan IV over 15 minutes on day -1 Patients undergo autologous peripheral blood stem cell transplantation on day 0 After transplantation patients in partial remission may undergo radiotherapy to nodal sites with residual tumor mass
Patients are followed every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 296-340 patients 148-170 per treatment arm will be accrued for this study within 4-5 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 |
|---|---|---|---|
| ISRCTN95614846 | Registry Identifier | PDQ Physician Data Query | None |
| EU-20042 | None | None | None |
| CDR0000068476 | REGISTRY | None | None |
| HOVON-44 | None | None | None |
| HOVON-44CKVO-2000-06 | None | None | None |