Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278421
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2006-01-16
Brief Title:
Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
German High-Grade Non-Hodgkins Lymphoma Study Group
Organization:
German High-Grade Non-Hodgkins Lymphoma Study Group
Study Overview
Official Title:
Randomized Study Comparing 4 and 6 Cycles of Chemotherapy With CHOP Cyclophosphamide Doxorubicin Vincristine and Prednisone at 21-day Intervals Both With 6 Cycles of Immunotherapy With the Monoclonal Anti-CD20-Positive B-Cell Lymphoma Aged 18-60 Years Having no Risk Factor Age-Adjusted IPI0 and No Large Tumor Mass Diameter 75cm FLYER 6-6-6-4 Study
Status:
COMPLETED
Status Verified Date:
2021-03
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 Monoclonal antibodies such as rituximab can block cancer growth in different ways Some find cancer cells and kill them or carry cancer-killing substances to them Others interfere with the ability of cancer cells to grow and spread Drugs used in chemotherapy such as cyclophosphamide doxorubicin vincristine and prednisone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving rituximab together with combination chemotherapy may kill more cancer cells It is not yet known which schedule of rituximab and combination chemotherapy is more effective in treating non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of 2 different schedules of immunochemotherapy comprising rituximab cyclophosphamide doxorubicin hydrochloride vincristine and prednisone in patients with previously untreated low-risk aggressive B-cell non-Hodgkins lymphoma
Compare acute and chronic side effects in patients treated with these regimens
Compare time to treatment failure in patients treated with these regimens
Secondary
Compare the time to progression in patients treated with these regimens
Compare the overall and disease-freerelapse-free survival of patients treated with these regimens
Compare the complete response rate in patients treated with these regimens
Compare the tumor control in patients treated with these regimens
Compare the safety of these regimens in these patients
Compare the pharmacoeconomics of these regimens
Compare patient adherence to these regimens
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
All patients are given the option of receiving a 1-week course of pretreatment therapy comprising vincristine IV once on day -6 and oral prednisone once daily on days -6 to 0
Arm I Patients receive R-CHOP immunochemotherapy comprising rituximab IV cyclophosphamide IV over 15 minutes doxorubicin hydrochloride IV and vincristine IV on day 1 and oral prednisone once daily on days 1-5 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Patients then undergo restaging of their disease Patients with disease progression proceed to salvage therapy off study All other patients receive 3 more courses of R-CHOP
Arm II Patients receive R-CHOP as in arm I Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Patients then undergo restaging of their disease Patients with disease progression proceed to salvage therapy off study All other patients receive 1 more course of R-CHOP followed by 2 courses of rituximab alone
All patients undergo final restaging after 6 courses of rituximab Patients with disease progression stable disease or partial response proceed to salvage therapy off study
After completion of study treatment patients are followed periodically for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 622 patients will be accrued for this study
Primary
Compare the efficacy of 2 different schedules of immunochemotherapy comprising rituximab cyclophosphamide doxorubicin hydrochloride vincristine and prednisone in patients with previously untreated low-risk aggressive B-cell non-Hodgkins lymphoma
Compare acute and chronic side effects in patients treated with these regimens
Compare time to treatment failure in patients treated with these regimens
Secondary
Compare the time to progression in patients treated with these regimens
Compare the overall and disease-freerelapse-free survival of patients treated with these regimens
Compare the complete response rate in patients treated with these regimens
Compare the tumor control in patients treated with these regimens
Compare the safety of these regimens in these patients
Compare the pharmacoeconomics of these regimens
Compare patient adherence to these regimens
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
All patients are given the option of receiving a 1-week course of pretreatment therapy comprising vincristine IV once on day -6 and oral prednisone once daily on days -6 to 0
Arm I Patients receive R-CHOP immunochemotherapy comprising rituximab IV cyclophosphamide IV over 15 minutes doxorubicin hydrochloride IV and vincristine IV on day 1 and oral prednisone once daily on days 1-5 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Patients then undergo restaging of their disease Patients with disease progression proceed to salvage therapy off study All other patients receive 3 more courses of R-CHOP
Arm II Patients receive R-CHOP as in arm I Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Patients then undergo restaging of their disease Patients with disease progression proceed to salvage therapy off study All other patients receive 1 more course of R-CHOP followed by 2 courses of rituximab alone
All patients undergo final restaging after 6 courses of rituximab Patients with disease progression stable disease or partial response proceed to salvage therapy off study
After completion of study treatment patients are followed periodically for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 622 patients will be accrued for this study
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 |
|---|---|---|---|
| DSHNHL-FLYER-6664 | None | None | None |
| DSHNHL-2004-2 | None | None | None |
| EU-205110 | None | None | None |
| EUDRACT-2005-00521738 | None | None | None |