Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032019
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2002-03-08
Brief Title:
Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Study Of Dose-Adjusted Epoch-Rituximab EPOCH-R Chemotherapy For Patients With Previously Untreated Aggressive CD20 B-Cell Non-Hodgkins Lymphoma NHL
Status:
COMPLETED
Status Verified Date:
2016-07
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 Combining rituximab with combination chemotherapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy in treating patients who have previously untreated non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy in treating patients who have previously untreated non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the response rate progression-free survival and overall survival of patients with previously untreated aggressive CD20 B-cell diffuse large cell or immunoblastic large cell lymphoma treated with rituximab doxorubicin etoposide vincristine prednisone and cyclophosphamide
Determine the toxic effects of this regimen in these patients
Correlate tumor proliferation rate MIB-1 bcl-2 expression and p53 overexpression with complete response rate progression-free survival and overall survival in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive rituximab IV on day 1 doxorubicin IV continuously etoposide IV continuously and vincristine IV continuously on days 1-4 oral prednisone twice daily on days 1-5 and cyclophosphamide IV on day 5 Patients also receive filgrastim G-CSF subcutaneously beginning on day 6 and continuing until blood counts recover Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity After 4 courses patients with complete or partial response receive 2 additional courses
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 25-50 patients will be accrued for this study within 1 year
Determine the response rate progression-free survival and overall survival of patients with previously untreated aggressive CD20 B-cell diffuse large cell or immunoblastic large cell lymphoma treated with rituximab doxorubicin etoposide vincristine prednisone and cyclophosphamide
Determine the toxic effects of this regimen in these patients
Correlate tumor proliferation rate MIB-1 bcl-2 expression and p53 overexpression with complete response rate progression-free survival and overall survival in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive rituximab IV on day 1 doxorubicin IV continuously etoposide IV continuously and vincristine IV continuously on days 1-4 oral prednisone twice daily on days 1-5 and cyclophosphamide IV on day 5 Patients also receive filgrastim G-CSF subcutaneously beginning on day 6 and continuing until blood counts recover Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity After 4 courses patients with complete or partial response receive 2 additional courses
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 25-50 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000069249 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-50103 | None | None | None |