Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073957
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2003-12-10
Brief Title:
Y 90 Ibritumomab Tiuxetan Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkins Lymphoma
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-12
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 Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkins lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab
Determine the event-free survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label multicenter study
Radioimmunotherapy Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 for imaging only yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8 and rituximab IV over 3-4 hours on days 1 8 15 22 29 and 36
CNS central nervous systemprophylaxis Patients receive CNS prophylaxis comprising intrathecal IT methotrexate or IT cytarabine on days 15 22 29 and 36 OR IT cytarabine liposomal on days 15 and 29
Maintenance rituximab Patients are assessed for response at week 14 Beginning at month 6 patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks Maintenance therapy repeats every 6 months for 2 years total of 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 years
Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkins lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab
Determine the event-free survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label multicenter study
Radioimmunotherapy Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 for imaging only yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8 and rituximab IV over 3-4 hours on days 1 8 15 22 29 and 36
CNS central nervous systemprophylaxis Patients receive CNS prophylaxis comprising intrathecal IT methotrexate or IT cytarabine on days 15 22 29 and 36 OR IT cytarabine liposomal on days 15 and 29
Maintenance rituximab Patients are assessed for response at week 14 Beginning at month 6 patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks Maintenance therapy repeats every 6 months for 2 years total of 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000341437 | REGISTRY | PDQ Physician Data Query | None |