Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Primary Central Nervous System Non-Hodgkin Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01973062|
Recruitment Status : Terminated (Funding Unavailable)
First Posted : October 31, 2013
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Primary Central Nervous System Non-Hodgkin Lymphoma||Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan||Phase 2|
I. Determine the radiographic response proportion in patients with refractory or recurrent primary central nervous system lymphoma (PCNSL) to ibritumomab tiuxetan (yttrium Y 90 ibritumomab tiuxetan) when given as an intravenous infusion.
I. Determine the progression free survival of patients treated with ibritumomab tiuxetan when given as an intravenous infusion.
II. Determine the overall survival of patients treated with ibritumomab tiuxetan when given as an intravenous infusion.
III. Establish the toxicity profile of ibritumomab tiuxetan in this patient population.
IV. Use positron emission tomography (PET)/magnetic resonance imaging (MRI) to map the distribution of Y-90 ibritumomab tiuxetan, and calculate the Gy delivered based on the activity found within tumor.
Patients receive rituximab intravenously (IV) on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity. Distribution and dose absorbed dose will be assessed on day 11. Quality of life will be assessed at screening, at day 1, 36, 92, and at each follow-up visit.
After completion of study treatment, patients are followed every 3-6 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Radioimmunotherapy With Zevalin (Ibritumomab Tiuxetan) Therapy for Patients With Refractory or Relapsed Primary Central Nervous System Lymphoma (PCNSL)|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: rituximab and yttrium Y 90 ibritumomab tiuxetan
Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.
Radiation: yttrium Y 90 ibritumomab tiuxetan
- Radiographic Response Assessed by MRI or FDG-PET/MRI [ Time Frame: Up to 2 years ]Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids
- Progression Free Survival [ Time Frame: Up to 2 years ]The number of patients without an unequivocal increase in tumor size or the appearance of new lesions by MRI
- Overall Survival [ Time Frame: Up to 2 years ]The number of patients alive up to two years after treatment
- Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population. [ Time Frame: Up to 30 days following the last dose of study treatment ]Number of patients with toxicities related to the study drug
- Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI [ Time Frame: At day 11 ]Number of Gy delivered to each tumor as calculated using the MIRD dosimetry formula on PET data
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): NCT01973062
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Manmeet Ahluwalia, MD||Case Comprehensive Cancer Center|