Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110149
Status:
TERMINATED
Last Update Posted:
2017-11-21
First Post:
2005-05-03
Brief Title:
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
A Phase II Study of Yttrium-90-Labeled Ibritumomab Tiuxetan Zevalin Radioimmunotherapy as First Line Treatment in Indolent Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company withdrew drug supply
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 block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others such as yttrium Y 90 ibritumomab tiuxetan find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells Giving rituximab together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells
PURPOSE This phase II trial is studying how well giving rituximab together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with indolent non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving rituximab together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with indolent non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine 12-week overall and complete response rate in patients with indolent non-Hodgkins lymphoma treated with rituximab and yttrium Y 90 ibritumomab tiuxetan as first-line treatment
Secondary
Determine 1-year event-free survival of patients treated with this regimen
Determine time to progression and time to next antilymphoma therapy in patients treated with this regimen
Determine the molecular response rate in patients treated with this regimen
Determine the hematological and non-hematological toxicity of this regimen in these patients
Assess the quality of life of patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive rituximab IV followed no more than 4 hours later by indium In 111 ibritumomab tiuxetan for imaging IV over 10 minutes on day 1 If biodistribution is acceptable patients receive rituximab IV followed no more than 4 hours later by a single dose of yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7 8 or 9 in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline weeks 6 10 and 14 every 3 months for 2 years and then every 6 months for 2 years
After completion of study treatment patients are followed weekly for 3 months every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 18-28 patients will be accrued for this study within 2 years
Primary
Determine 12-week overall and complete response rate in patients with indolent non-Hodgkins lymphoma treated with rituximab and yttrium Y 90 ibritumomab tiuxetan as first-line treatment
Secondary
Determine 1-year event-free survival of patients treated with this regimen
Determine time to progression and time to next antilymphoma therapy in patients treated with this regimen
Determine the molecular response rate in patients treated with this regimen
Determine the hematological and non-hematological toxicity of this regimen in these patients
Assess the quality of life of patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive rituximab IV followed no more than 4 hours later by indium In 111 ibritumomab tiuxetan for imaging IV over 10 minutes on day 1 If biodistribution is acceptable patients receive rituximab IV followed no more than 4 hours later by a single dose of yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7 8 or 9 in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline weeks 6 10 and 14 every 3 months for 2 years and then every 6 months for 2 years
After completion of study treatment patients are followed weekly for 3 months every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 18-28 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 |
|---|---|---|---|
| CDR0000409723 | REGISTRY | None | None |
| NCI-2011-02445 | REGISTRY | CTRP Clinical Trials Reporting System | None |