Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004179
Status:
COMPLETED
Last Update Posted:
2021-02-15
First Post:
2000-01-21
Brief Title:
Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkins Lymphoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Chimeric Anti-CD20 Monoclonal Antibody Mabthera in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkins Lymphoma A Phase III Randomized Clinical Trial - Intergroup Collaborative Study
Status:
COMPLETED
Status Verified Date:
2021-02
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 chemotherapy is more effective with or without rituximab for relapsed non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the response rate and quality of remission in patients with relapsed follicular non-Hodgkins lymphoma treated with cyclophosphamide doxorubicin vincristine and prednisone CHOP with or without rituximab
Compare the event-free survival and overall survival of patients treated with these regimens
Determine the effect of rituximab as maintenance therapy on progression-free survival of these patients
OUTLINE This is a randomized multicenter study
Induction Patients are randomized to one of two treatment arms Patients are stratified according to participating center prior treatment with purine analogues age number of prior induction treatments and best response obtained complete vs partial remission vs no changeprogressive disease time since diagnosis less than 2 years vs more than 2 years and bulky disease less than 10 cm vs greater than 10 cm
Arm I closed as of 122004 Patients receive induction chemotherapy comprising cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 CHOP chemotherapy Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive CHOP chemotherapy as in arm I Rituximab IV is administered 1 hour after prednisone and before the IV drugs
Maintenance Patients who achieve partial or complete remission are then randomized to one of two treatment arms Patients are stratified according to rituximab administration during induction yes vs no quality of the response complete vs partial remission vs no changeprogressive disease and participating center
Arm I Patients receive no further therapy
Arm II Beginning 8 weeks after the last CHOP course patients receive rituximab IV once every 3 months for up to 2 years in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 4 months thereafter
PROJECTED ACCRUAL A total of 752 patients will be accrued for this study within 6 years
Compare the response rate and quality of remission in patients with relapsed follicular non-Hodgkins lymphoma treated with cyclophosphamide doxorubicin vincristine and prednisone CHOP with or without rituximab
Compare the event-free survival and overall survival of patients treated with these regimens
Determine the effect of rituximab as maintenance therapy on progression-free survival of these patients
OUTLINE This is a randomized multicenter study
Induction Patients are randomized to one of two treatment arms Patients are stratified according to participating center prior treatment with purine analogues age number of prior induction treatments and best response obtained complete vs partial remission vs no changeprogressive disease time since diagnosis less than 2 years vs more than 2 years and bulky disease less than 10 cm vs greater than 10 cm
Arm I closed as of 122004 Patients receive induction chemotherapy comprising cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 CHOP chemotherapy Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive CHOP chemotherapy as in arm I Rituximab IV is administered 1 hour after prednisone and before the IV drugs
Maintenance Patients who achieve partial or complete remission are then randomized to one of two treatment arms Patients are stratified according to rituximab administration during induction yes vs no quality of the response complete vs partial remission vs no changeprogressive disease and participating center
Arm I Patients receive no further therapy
Arm II Beginning 8 weeks after the last CHOP course patients receive rituximab IV once every 3 months for up to 2 years in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 4 months thereafter
PROJECTED ACCRUAL A total of 752 patients will be accrued for this study within 6 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 |
|---|---|---|---|
| NORDIC-EORTC-20981 | OTHER | NLG | None |
| EORTC-20981 | OTHER | None | None |
| ALLG-NHLLOW4 | OTHER | None | None |
| BNLI-EORTC-20981 | OTHER | None | None |
| HOVON-H039 | OTHER | None | None |
| CAN-NCIC-LY7 | OTHER | None | None |