Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064116
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
2003-07-08
Brief Title:
Combination Chemotherapy With or Without Rituximab in Non-Hodgkins Lymphoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
Randomized Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkins Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab
Status:
COMPLETED
Status Verified Date:
2020-03
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:
IDEC-C2B8
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 is more effective with or without rituximab in treating patients with non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the time to treatment failure in patients with CD20-positive diffuse large B-cell non-Hodgkins lymphoma treated with CHOP cyclophosphamide doxorubicin vincristine and prednisone-like chemotherapy with vs without rituximab
Compare the tumor control progression rate and complete remission rate in patients treated with these regimens
Compare the disease-free and overall survival rate of patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center bulky disease no vs yes International Prognostic Index score 0 vs 1 and chemotherapy CHOP vs CHOEP vs PMitCEBO vs MACOP-B Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive 1 of the following chemotherapy regimens according to participating country
CHOP Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisone or prednisolone on days 1-5 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
CHOEP-21 Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 etoposide IV on days 1-3 and oral prednisone on days 1-5 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
PMitCEBO Patients receive mitoxantrone IV cyclophosphamide IV and etoposide IV on day 1 vincristine IV and bleomycin IV on day 8 and oral prednisolone daily during weeks 1-4 and every other day during week 5 Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity
MACOP-B Patients receive cyclophosphamide IV and doxorubicin IV on days 1 15 29 43 57 and 71 methotrexate IV and vincristine IV on days 8 36 and 64 bleomycin IV and vincristine IV on days 22 50 and 78 and oral or intramuscular prednisone on days 1-84 Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive arm I regimens according to participating country and rituximab as follows
CHOP and rituximab Patients receive CHOP as in arm I and rituximab IV on day 1
CHOEP-21 and rituximab Patients receive CHOEP-21 as in arm I and rituximab IV on day 1
PMitCEBO and rituximab Patients receive PMitCEBO as in arm I and rituximab IV on day 1 during courses 1 and 4 on day 8 during courses 2 and 5 and on day 1 at 1 and 4 weeks after completion of the last course of PMitCEBO chemotherapy
MACOP-B and rituximab Patients receive MACOP-B as in arm I and rituximab IV on days 1 22 43 64 85 and 106
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 820 patients will be accrued for this study within approximately 2 years
Compare the time to treatment failure in patients with CD20-positive diffuse large B-cell non-Hodgkins lymphoma treated with CHOP cyclophosphamide doxorubicin vincristine and prednisone-like chemotherapy with vs without rituximab
Compare the tumor control progression rate and complete remission rate in patients treated with these regimens
Compare the disease-free and overall survival rate of patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center bulky disease no vs yes International Prognostic Index score 0 vs 1 and chemotherapy CHOP vs CHOEP vs PMitCEBO vs MACOP-B Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive 1 of the following chemotherapy regimens according to participating country
CHOP Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisone or prednisolone on days 1-5 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
CHOEP-21 Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 etoposide IV on days 1-3 and oral prednisone on days 1-5 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
PMitCEBO Patients receive mitoxantrone IV cyclophosphamide IV and etoposide IV on day 1 vincristine IV and bleomycin IV on day 8 and oral prednisolone daily during weeks 1-4 and every other day during week 5 Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity
MACOP-B Patients receive cyclophosphamide IV and doxorubicin IV on days 1 15 29 43 57 and 71 methotrexate IV and vincristine IV on days 8 36 and 64 bleomycin IV and vincristine IV on days 22 50 and 78 and oral or intramuscular prednisone on days 1-84 Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive arm I regimens according to participating country and rituximab as follows
CHOP and rituximab Patients receive CHOP as in arm I and rituximab IV on day 1
CHOEP-21 and rituximab Patients receive CHOEP-21 as in arm I and rituximab IV on day 1
PMitCEBO and rituximab Patients receive PMitCEBO as in arm I and rituximab IV on day 1 during courses 1 and 4 on day 8 during courses 2 and 5 and on day 1 at 1 and 4 weeks after completion of the last course of PMitCEBO chemotherapy
MACOP-B and rituximab Patients receive MACOP-B as in arm I and rituximab IV on days 1 22 43 64 85 and 106
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 820 patients will be accrued for this study within approximately 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| CDR0000309053 | OTHER | PDQ | None |
| CAN-NCIC-LY9 | None | None | None |
| ROCHE-CAN-NCIC-LY9 | OTHER | None | None |
| MINT-M39045 | None | None | None |