Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075946
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2004-01-12
Brief Title:
Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkins Lymphoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2024-01
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 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 which rituximab regimen is more effective in treating indolent non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkins lymphoma or stage IV non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkins lymphoma or stage IV non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
To compare time to rituximab failure between the rituximab scheduled and rituximab retreatment arms
Secondary
To compare the time to first cytotoxic therapy between the rituximab scheduled and rituximab retreatment arms
To document the rationale for beginning cytotoxic therapy defined as chemotherapy radiation therapy or radioimmunotherapy
To compare the toxicities associated with rituximab therapy between the two randomized treatment arms
Quality of Life Objectives
1 To compare health-related quality of life distress psychological functioning physical well-being and functional well-being of patients receiving rituximab scheduled to those receiving rituximab retreatment
2 To examine the impact of differential treatment response delayed time to rituximab failure andor time to first cytotoxic therapy if observed on quality of life distress and psychological functioning on patients receiving rituximab scheduled to those receiving rituximab retreatment
3 To obtain prospective data on physical and functional well-being during treatment with rituximab
OUTLINE This is a randomized multicenter study Patients are stratified according to histologic subtype follicular vs other age under 60 vs 60 and over and the time from diagnosis less than 1 year vs at least 1 year
Induction rituximab Patients receive rituximab Intravenous IV once a week for 4 weeks
Patients are re-evaluated 9 weeks after the completion of induction rituximab Patients with a partial or complete response to induction rituximab are randomized to 1 of 2 treatment arms
Arm A retreatment rituximab Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months
Arm B scheduled rituximab Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity
Quality of life is assessed after induction rituximab treatment and at 26 39 65 117 169 and 221 weeks after randomization
Patients are followed at least annually for 15 years from study entry
Primary
To compare time to rituximab failure between the rituximab scheduled and rituximab retreatment arms
Secondary
To compare the time to first cytotoxic therapy between the rituximab scheduled and rituximab retreatment arms
To document the rationale for beginning cytotoxic therapy defined as chemotherapy radiation therapy or radioimmunotherapy
To compare the toxicities associated with rituximab therapy between the two randomized treatment arms
Quality of Life Objectives
1 To compare health-related quality of life distress psychological functioning physical well-being and functional well-being of patients receiving rituximab scheduled to those receiving rituximab retreatment
2 To examine the impact of differential treatment response delayed time to rituximab failure andor time to first cytotoxic therapy if observed on quality of life distress and psychological functioning on patients receiving rituximab scheduled to those receiving rituximab retreatment
3 To obtain prospective data on physical and functional well-being during treatment with rituximab
OUTLINE This is a randomized multicenter study Patients are stratified according to histologic subtype follicular vs other age under 60 vs 60 and over and the time from diagnosis less than 1 year vs at least 1 year
Induction rituximab Patients receive rituximab Intravenous IV once a week for 4 weeks
Patients are re-evaluated 9 weeks after the completion of induction rituximab Patients with a partial or complete response to induction rituximab are randomized to 1 of 2 treatment arms
Arm A retreatment rituximab Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months
Arm B scheduled rituximab Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity
Quality of life is assessed after induction rituximab treatment and at 26 39 65 117 169 and 221 weeks after randomization
Patients are followed at least annually for 15 years from study entry
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 |
|---|---|---|---|
| ECOG-E4402 | OTHER | Eastern Cooperative Oncology Group | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |