Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006721
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2000-12-06
Brief Title:
S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkins Lymphoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody Tositumomab for Treatment of Newly Diagnosed Follicular Non-Hodgkins Lymphomas
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 cancer cells from dividing so they stop growing or die Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the progression-free survival and overall survival of patients with newly diagnosed follicular non-Hodgkins lymphoma treated with cyclophosphamide doxorubicin vincristine and prednisone CHOP with or without either rituximab or iodine I 131 tositumomab monoclonal antibody anti-B1 CHOP chemotherapy alone arm closed to accrual as of 121502
Compare the response rate of these patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the molecular remission rates of this patient population treated with these regimens
Determine the incidence and time to development of human anti-mouse antibody positivity
OUTLINE This is a randomized multicenter study Patients are stratified according to whether microglobulin is greater than upper limit of normal yes vs no Patients are randomized to 1 of 3 treatment arms Arm I closed to accrual as of 121502
Arm I CHOP only Patients receive cyclophosphamide IV over 15 minutes doxorubicin IV over 5-20 minutes and vincristine IV over 5-15 minutes on day 1 Patients also receive oral prednisone daily on days 1-5 Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Arm I closed to accrual as of 121502
Arm II CHOP rituximab Patients receive cyclophosphamide IV over 15 minutes doxorubicin IV over 5-20 minutes and vincristine IV over 5-15 minutes on days 8 29 50 71 92 and 113 Patients also receive oral prednisone daily on days 8-12 29-33 50-54 71-75 and 113-117 and rituximab IV over 4-6 hours on days 1 6 48 90 134 and 141
Arm III CHOP tositumomab Patients receive chemotherapy as in arm I and tositumomab monoclonal antibody anti-B1 IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
Patients are followed on day 200 at 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 500 patients 250 per treatment arm will be accrued for this study within 55 years Arm I closed to accrual as of 121502
Compare the progression-free survival and overall survival of patients with newly diagnosed follicular non-Hodgkins lymphoma treated with cyclophosphamide doxorubicin vincristine and prednisone CHOP with or without either rituximab or iodine I 131 tositumomab monoclonal antibody anti-B1 CHOP chemotherapy alone arm closed to accrual as of 121502
Compare the response rate of these patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the molecular remission rates of this patient population treated with these regimens
Determine the incidence and time to development of human anti-mouse antibody positivity
OUTLINE This is a randomized multicenter study Patients are stratified according to whether microglobulin is greater than upper limit of normal yes vs no Patients are randomized to 1 of 3 treatment arms Arm I closed to accrual as of 121502
Arm I CHOP only Patients receive cyclophosphamide IV over 15 minutes doxorubicin IV over 5-20 minutes and vincristine IV over 5-15 minutes on day 1 Patients also receive oral prednisone daily on days 1-5 Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Arm I closed to accrual as of 121502
Arm II CHOP rituximab Patients receive cyclophosphamide IV over 15 minutes doxorubicin IV over 5-20 minutes and vincristine IV over 5-15 minutes on days 8 29 50 71 92 and 113 Patients also receive oral prednisone daily on days 8-12 29-33 50-54 71-75 and 113-117 and rituximab IV over 4-6 hours on days 1 6 48 90 134 and 141
Arm III CHOP tositumomab Patients receive chemotherapy as in arm I and tositumomab monoclonal antibody anti-B1 IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
Patients are followed on day 200 at 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 500 patients 250 per treatment arm will be accrued for this study within 55 years Arm I closed to accrual as of 121502
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S0016 | OTHER | ECOG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |
| S0016 | OTHER | None | None |
| CALGB-50102 | OTHER | None | None |