Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062114
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2003-06-05
Brief Title:
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab 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:
A Phase II Study To Evaluate The Safety And Efficacy Of Zevalin IND BB IND 4850 Therapeutic Regimen In Patients With Transformed CD20 B-Cell Non-Hodgkins Lymphoma
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 Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells
PURPOSE This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with progressive non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with progressive non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the efficacy of yttrium Y 90 ibritumomab tiuxetan and rituximab in terms of overall response rate complete unconfirmed complete and partial and duration of response in patients with transformed CD20 B-cell non-Hodgkins lymphoma
Determine the safety of this regimen in these patients
Determine the event-free survival and time to treatment progression in patients treated with this regimen
Determine the immunogenicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive rituximab IV followed within 4 hours by indium In 111 ibritumomab tiuxetan IV for imaging over 10 minutes on day 1 Patients undergo 1 or 2 if needed imaging scan between days 2-5 In the absence of altered biodistribution patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8
Patients are followed monthly for 3 months every 3 months for 2 years and then every 6 months for 2 years
Determine the efficacy of yttrium Y 90 ibritumomab tiuxetan and rituximab in terms of overall response rate complete unconfirmed complete and partial and duration of response in patients with transformed CD20 B-cell non-Hodgkins lymphoma
Determine the safety of this regimen in these patients
Determine the event-free survival and time to treatment progression in patients treated with this regimen
Determine the immunogenicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive rituximab IV followed within 4 hours by indium In 111 ibritumomab tiuxetan IV for imaging over 10 minutes on day 1 Patients undergo 1 or 2 if needed imaging scan between days 2-5 In the absence of altered biodistribution patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8
Patients are followed monthly for 3 months every 3 months for 2 years and then every 6 months for 2 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 |
|---|---|---|---|
| CALGB-50201 | None | None | None |
| CDR0000304498 | REGISTRY | NCI Physician Data Query | None |