Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028717
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2002-01-04
Brief Title:
Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkins Lymphoma
Sponsor:
Commissie Voor Klinisch Toegepast Onderzoek
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Study Of Chimeric Anti-CD20 Monoclonal Antibody Rituximab With 2-Weekly CHOP Chemotherapy In Elderly Patients With Intermediate Or High-Risk Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2007-11
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells It is not yet known if combination chemotherapy plus filgrastim is more effective with or without rituximab in treating non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to determine the effectiveness of combination chemotherapy plus filgrastim with or without rituximab in treating older patients who have non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to determine the effectiveness of combination chemotherapy plus filgrastim with or without rituximab in treating older patients who have non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the efficacy of cyclophosphamide doxorubicin vincristine prednisone CHOP and filgrastim G-CSF with or without rituximab on event-free survival of elderly patients with intermediate or high-risk non-Hodgkins lymphoma
Compare the complete remission rate overall survival and disease-free survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center WHO classification and International Prognostic Index score Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 oral prednisone on days 1-5 and filgrastim G-CSF subcutaneously on days 1-14 Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive cyclophosphamide doxorubicin vincristine prednisone and G-CSF as in arm I Patients also receive rituximab IV on day 3 of courses 1-2 and on day 1 of courses 3-6 for a total of 6 doses
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 400 patients 200 per treatment arm will be accrued for this study within 5 years
Compare the efficacy of cyclophosphamide doxorubicin vincristine prednisone CHOP and filgrastim G-CSF with or without rituximab on event-free survival of elderly patients with intermediate or high-risk non-Hodgkins lymphoma
Compare the complete remission rate overall survival and disease-free survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center WHO classification and International Prognostic Index score Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 oral prednisone on days 1-5 and filgrastim G-CSF subcutaneously on days 1-14 Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive cyclophosphamide doxorubicin vincristine prednisone and G-CSF as in arm I Patients also receive rituximab IV on day 3 of courses 1-2 and on day 1 of courses 3-6 for a total of 6 doses
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 400 patients 200 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 |
|---|---|---|---|
| HOVON-CKVO-2000-10 | None | None | None |
| CKTO-2000-10 | None | None | None |
| HOVON-46NHL | None | None | None |
| EU-20130 | None | None | None |