Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004112
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-Hodgkins Lymphoma
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
A Phase III Randomized Trial of CHOP Chemotherapy Plus Rituxan IDEC-C2B8 Versus CHOP Chemotherapy Alone for Newly Diagnosed Previously Untreated Aggressive Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2024-09
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 cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells It is not yet known whether combination chemotherapy plus rituximab is more effective than combination chemotherapy alone for non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating patients who have newly diagnosed non-Hodgkins lymphoma that has not been treated previously
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating patients who have newly diagnosed non-Hodgkins lymphoma that has not been treated previously
Detailed Description:
OBJECTIVES I Determine whether the addition of rituximab to cyclophosphamide doxorubicin vincristine and prednisone CHOP increases the failure-free survival of patients with newly diagnosed previously untreated aggressive B-cell non-Hodgkins lymphoma II Determine whether the addition of rituximab changes the toxicity profile attributed to CHOP chemotherapy in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified by center histology diffuse small cleaved cell diffuse mixed and diffuse large cell vs immunoblastic large cell mantle cell and marginal zone and risk group low vs intermediate vs high Patients enter one of two treatment arms Arm I Patients receive rituximab IV on day 1 followed by cyclophosphamide IV doxorubicin IV vincristine IV and oral prednisone for 5 consecutive days beginning on day 3 Arm II Patients receive cyclophosphamide IV doxorubicin IV vincristine IV and oral prednisone daily for 5 consecutive days beginning on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients will be followed for 3 years
PROJECTED ACCRUAL A total of 270 patients 135 per treatment arm will be accrued for this study within 3 years
OUTLINE This is a randomized multicenter study Patients are stratified by center histology diffuse small cleaved cell diffuse mixed and diffuse large cell vs immunoblastic large cell mantle cell and marginal zone and risk group low vs intermediate vs high Patients enter one of two treatment arms Arm I Patients receive rituximab IV on day 1 followed by cyclophosphamide IV doxorubicin IV vincristine IV and oral prednisone for 5 consecutive days beginning on day 3 Arm II Patients receive cyclophosphamide IV doxorubicin IV vincristine IV and oral prednisone daily for 5 consecutive days beginning on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients will be followed for 3 years
PROJECTED ACCRUAL A total of 270 patients 135 per treatment arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA036727 | NIH | None | None |
| UCLA-HSPC-9812071 | OTHER | None | None |
| NCI-G99-1601 | OTHER_GRANT | National Cancer Institute NCI | httpsreporternihgovquickSearchP30CA036727 |