Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003150
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Older Patients With Non-Hodgkins Lymphoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial of CHOP Versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody IDEC-C2B8 in Older Patients With Diffuse Mixed Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2010-08
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 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 if combination chemotherapy is more effective with or without rituximab for non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating older patients who have non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating older patients who have non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Compare the efficacy of CHOP cyclophosphamide doxorubicin vincristine and prednisone with or without rituximab in older patients with diffuse mixed diffuse large or immunoblastic large cell non-Hodgkins lymphoma of B-cell lineage with respect to the response rate time to treatment failure toxicity and survival II Compare the efficacy of maintenance therapy consisting of rituximab vs observation alone after initial therapy with respect to the time to treatment failure duration of response toxicity and survival of this patient population III Determine if maintenance therapy with rituximab results in the conversion of any partial response to complete response
OUTLINE This is a randomized study For the first randomization patients are stratified according to the number of risk factors 0-1 vs 2-4 For the second randomization in addition to the number of risk factors patients are stratified according to objective response to initial induction therapy partial response vs complete response and induction therapy CHOP vs CHOP and rituximab Patients are randomized to one of two treatment arms Arm I Patients receive CHOP chemotherapy comprising cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 Treatment repeats every 21 days in the absence of unacceptable toxicity Arm II Patients receive treatment as in arm I Patients also receive rituximab IV on days -7-3 41 and 83 Patients who achieve complete response CR after 4 courses of CHOP and remain in CR after 6 courses of CHOP are further randomized to one of two arms Arm I Maintenance therapy Patients receive rituximab IV weekly for 4 weeks Courses repeat every 6 months for 2 years in the absence of unacceptable toxicity Arm II Patients are observed Patients who achieve partial response PR after 6 courses OR PR after 4 courses and then CR after 6 courses receive 2 additional courses of CHOP therapy Patients are then also randomized to receive either maintenance therapy or observation as above Patients with stable disease or disease progression are removed from the study Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 630 patients will be accrued for this study within 4 years
OUTLINE This is a randomized study For the first randomization patients are stratified according to the number of risk factors 0-1 vs 2-4 For the second randomization in addition to the number of risk factors patients are stratified according to objective response to initial induction therapy partial response vs complete response and induction therapy CHOP vs CHOP and rituximab Patients are randomized to one of two treatment arms Arm I Patients receive CHOP chemotherapy comprising cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 Treatment repeats every 21 days in the absence of unacceptable toxicity Arm II Patients receive treatment as in arm I Patients also receive rituximab IV on days -7-3 41 and 83 Patients who achieve complete response CR after 4 courses of CHOP and remain in CR after 6 courses of CHOP are further randomized to one of two arms Arm I Maintenance therapy Patients receive rituximab IV weekly for 4 weeks Courses repeat every 6 months for 2 years in the absence of unacceptable toxicity Arm II Patients are observed Patients who achieve partial response PR after 6 courses OR PR after 4 courses and then CR after 6 courses receive 2 additional courses of CHOP therapy Patients are then also randomized to receive either maintenance therapy or observation as above Patients with stable disease or disease progression are removed from the study Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 630 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| SWOG-E4494 | None | None | None |
| ECOG-E4494 | None | None | None |
| CLB-9793 | None | None | None |