Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00110149|
Recruitment Status : Terminated (Company withdrew drug supply)
First Posted : May 4, 2005
Results First Posted : November 21, 2017
Last Update Posted : November 21, 2017
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-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan||Phase 2|
- Determine 12-week overall and complete response rate in patients with indolent non-Hodgkin's lymphoma treated with rituximab and yttrium Y 90 ibritumomab tiuxetan as first-line treatment.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Yttrium-90-Labeled Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as First Line Treatment in Indolent Non-Hodgkin's Lymphoma|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||March 2015|
Experimental: Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Radiation: yttrium Y 90 ibritumomab tiuxetan
- Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks [ Time Frame: 14 weeks ]
INTERNATIONAL WORKSHOP RESPONSE CRITERIA FOR NON HODGKIN'S LYMPHOMA
Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non Hodgkin's lymphoma. J Clin Oncol 1999;17(4):1244-53.
- EFS [ Time Frame: 1 year ]Event = Death, second malignancy , disease progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110149
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|United States, Vermont|
|Vermont Cancer Center at University of Vermont|
|Burlington, Vermont, United States, 05401-3498|
|Study Chair:||Robin Joyce, MD||Beth Israel Deaconess Medical Center|