Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052936
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2003-01-24
Brief Title:
Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkins Lymphoma
Sponsor:
German High-Grade Non-Hodgkins Lymphoma Study Group
Organization:
Universität des Saarlandes
Study Overview
Official Title:
Randomised Study Comparing 6 And 8 Cycles Of Chemotherapy With CHOP Cyclophosphamide Doxorubicin Vincristine And Prednisone At 14-Day Intervals CHOP-14 Both With Or Without The Monoclonal Anti-CD20 Antibody Rituximab In Patients Aged 61 To 80 Years With Aggressive Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2021-05
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 tumor cells and either kill them or deliver tumor-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 aggressive non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying how well giving cyclophosphamide doxorubicin vincristine and prednisone together with or without rituximab works in treating older patients who have aggressive non-Hodgkins lymphoma This trial is no longer randomized as of 62005
PURPOSE This randomized phase III trial is studying how well giving cyclophosphamide doxorubicin vincristine and prednisone together with or without rituximab works in treating older patients who have aggressive non-Hodgkins lymphoma This trial is no longer randomized as of 62005
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of cyclophosphamide doxorubicin vincristine and prednisone CHOP with vs without rituximab in elderly patients with aggressive non-Hodgkins lymphoma
Compare the efficacy of 6 vs 8 courses of CHOP chemotherapy in patients treated with these regimens
Compare the rate of complete remission rate of primary progression tumor control disease-free survival overall survival and relapse after radiotherapy in patients treated with these regimens
Compare the safety and side effects of these regimens in these patients
Secondary
Compare short-term and long-term side effects of these regimens in these patients
Compare quality of life of patients treated with these regimens
Compare the cost of these regimens in these patients
Determine relapse in patients treated with these regimens who received involved-field radiotherapy
OUTLINE This is a randomized randomized part of study completed as of 62005 open-label multicenter study Patients are stratified according to participating center value for serum lactic dehydrogenase no greater than upper limit of normal ULN vs greater than ULN bulky disease present no vs yes stage I or II vs III or IV general ECOG status of patient 0 or 1 vs 2 and age 61 to 70 vs 71-80 Patients are randomized to 1 of 4 treatment arms Patients with CD20-negative lymphoma are randomized to arms I or II only
Prephase treatmentPatients receive vincristine IV on day -6 and prednisone on day -6 to day 0 before initiating CHOP chemotherapy
Arm I closed to accrual as of 7252005 Patients receive standard CHOP chemotherapy comprising cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 Patients also receive filgrastim G-CSF subcutaneously once daily on days 6-12 of each CHOP course Treatment repeats every 2 weeks for 6 courses
Arm II closed to accrual as of 7252005 Patients receive standard CHOP chemotherapy and G-CSF as in arm I for a total of 8 courses
Arm III Patients receive standard CHOP chemotherapy and G-CSF as in arm I Patients also receive rituximab IV before CHOP every 2 weeks for a total of 8 courses
Arm IV closed to accrual as of 7252005 Patients receive standard CHOP chemotherapy and G-CSF as in arm II Patients also receive rituximab IV before CHOP every 2 weeks for a total of 8 courses
In all arms treatment continues in the absence of disease progression or unacceptable toxicity
Beginning 3-6 weeks after completion of the last chemotherapy course after complete recovery of bone marrow and after complete remision of mucositis patients with sites of initial bulky disease or extranodal involvement undergo radiotherapy 5 times a week for 4 weeks
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 1580 patients will be accrued for this study within 5 years
Primary
Compare the efficacy of cyclophosphamide doxorubicin vincristine and prednisone CHOP with vs without rituximab in elderly patients with aggressive non-Hodgkins lymphoma
Compare the efficacy of 6 vs 8 courses of CHOP chemotherapy in patients treated with these regimens
Compare the rate of complete remission rate of primary progression tumor control disease-free survival overall survival and relapse after radiotherapy in patients treated with these regimens
Compare the safety and side effects of these regimens in these patients
Secondary
Compare short-term and long-term side effects of these regimens in these patients
Compare quality of life of patients treated with these regimens
Compare the cost of these regimens in these patients
Determine relapse in patients treated with these regimens who received involved-field radiotherapy
OUTLINE This is a randomized randomized part of study completed as of 62005 open-label multicenter study Patients are stratified according to participating center value for serum lactic dehydrogenase no greater than upper limit of normal ULN vs greater than ULN bulky disease present no vs yes stage I or II vs III or IV general ECOG status of patient 0 or 1 vs 2 and age 61 to 70 vs 71-80 Patients are randomized to 1 of 4 treatment arms Patients with CD20-negative lymphoma are randomized to arms I or II only
Prephase treatmentPatients receive vincristine IV on day -6 and prednisone on day -6 to day 0 before initiating CHOP chemotherapy
Arm I closed to accrual as of 7252005 Patients receive standard CHOP chemotherapy comprising cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 Patients also receive filgrastim G-CSF subcutaneously once daily on days 6-12 of each CHOP course Treatment repeats every 2 weeks for 6 courses
Arm II closed to accrual as of 7252005 Patients receive standard CHOP chemotherapy and G-CSF as in arm I for a total of 8 courses
Arm III Patients receive standard CHOP chemotherapy and G-CSF as in arm I Patients also receive rituximab IV before CHOP every 2 weeks for a total of 8 courses
Arm IV closed to accrual as of 7252005 Patients receive standard CHOP chemotherapy and G-CSF as in arm II Patients also receive rituximab IV before CHOP every 2 weeks for a total of 8 courses
In all arms treatment continues in the absence of disease progression or unacceptable toxicity
Beginning 3-6 weeks after completion of the last chemotherapy course after complete recovery of bone marrow and after complete remision of mucositis patients with sites of initial bulky disease or extranodal involvement undergo radiotherapy 5 times a week for 4 weeks
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 1580 patients will be accrued for this study within 5 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 |
|---|---|---|---|
| EU-20243 | OTHER | Ethikkommission der Ärztekammer des Saarlandes 8599 | None |
| DSHNHL-1999-1A | OTHER_GRANT | None | None |