Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005959
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkins Lymphoma
Sponsor:
Amgen
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated Intermediate or High Grade Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2002-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one chemotherapy drug with rituximab may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have intermediate-grade or high-grade non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have intermediate-grade or high-grade non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the rate of complete response and partial response in patients with intermediate or high grade non-Hodgkins lymphoma treated with rituximab plus cyclophosphamide doxorubicin vincristine and prednisone CHOP II Determine the toxicity of this regimen in these patients III Determine the disease-free and overall survival time to response and time to disease progression in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to the number of risk factors 0-2 vs 3-5 Risk factors include age no greater than 60 vs greater than 60 tumor stage II vs III or IV number of extranodal sites no more than 1 vs more than 1 performance status 0-1 vs 2-4 and serum LDH level no greater than normal vs greater than normal Patients receive rituximab IV on day 1 cyclophosphamide doxorubicin and vincristine IV on day 3 and oral prednisone on days 3-7 Patients over 60 also receive filgrastim G-CSF subcutaneously beginning on day 4 and continuing until blood counts recover all other patients receive G-CSF as secondary prophylaxis Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients who respond receive 2 more courses Patients who have no measurable disease after 6 courses receive rituximab IV once weekly for 4 consecutive weeks This treatment continues every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity Patients who have measurable disease after 6 courses of chemotherapy receive 2 more courses for a maximum of 8 courses of CHOP followed by maintenance therapy with rituximab as described above Patients are followed every 6 months for 2 years
PROJECTED ACCRUAL Approximately 100 patients will be accrued for this study
OUTLINE This is a multicenter study Patients are stratified according to the number of risk factors 0-2 vs 3-5 Risk factors include age no greater than 60 vs greater than 60 tumor stage II vs III or IV number of extranodal sites no more than 1 vs more than 1 performance status 0-1 vs 2-4 and serum LDH level no greater than normal vs greater than normal Patients receive rituximab IV on day 1 cyclophosphamide doxorubicin and vincristine IV on day 3 and oral prednisone on days 3-7 Patients over 60 also receive filgrastim G-CSF subcutaneously beginning on day 4 and continuing until blood counts recover all other patients receive G-CSF as secondary prophylaxis Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients who respond receive 2 more courses Patients who have no measurable disease after 6 courses receive rituximab IV once weekly for 4 consecutive weeks This treatment continues every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity Patients who have measurable disease after 6 courses of chemotherapy receive 2 more courses for a maximum of 8 courses of CHOP followed by maintenance therapy with rituximab as described above Patients are followed every 6 months for 2 years
PROJECTED ACCRUAL Approximately 100 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 |
|---|---|---|---|
| NCI-V00-1593 | None | None | None |
| AMGEN-GCSF-990756 | None | None | None |