Y90 Ibritumomab Tiuxetan Post R-CHOP Chemotherapy for Advanced Stage Follicular Lymphoma (ZEVISS)
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|ClinicalTrials.gov Identifier: NCT01446562|
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : June 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma||Biological: Y90 Ibritumomab Tiuxetan RIT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Y90 Ibritumomab Tiuxetan Post Rituximab-Cyclophosphamide, Doxobrubicn, Vincristine and Prednisone (R-CHOP) Chemotherapy for Newly Diagnosed Patients With Advanced Stage Follicular Lymphoma|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Experimental: Y90 Ibritumomab Tiuxetan
Addition of Y90 Ibritumomab Tiuxetan RIT to CHOP-R treatment for follicular lymphoma-patients also receive maintenance Rituximab every 3 months for 2 years after the Y90 Ibritumomab Tiuxetan
Biological: Y90 Ibritumomab Tiuxetan RIT
Other Name: Zevalin
- The primary endpoint for this study is the complete response rate measured 3 months after the dose of 90Y-RIT [ Time Frame: 3 months after the dose of 90Y-RIT ]The primary endpoint for the study is the final complete response (CR) rate, defined according to International Working Group criteria 24, and measured 3 months after completion of the treatment (measured from day 1 of the 90Y-RIT therapy). Hence, CR implies the elimination of all lymphoma manifestations including complete disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms if present before therapy.
- toxicities [ Time Frame: entry into trial until 6 weeks post 90Y ibritumomab tiuxetan treatment (week 30) ]Toxicity associated with R-CHOP induction and 90Y ibritumomab tiuxetan treatment will be assessed by monitoring the incidence, severity, and type of adverse events. Adverse events will be recorded according to the NCI CTCAE . In addition, changes in physical examination findings, vital signs, and clinical laboratory results (complete blood count, differential, and chemistry) will be documented.
- Conversion of partial responses to complete responses [ Time Frame: 6 weeks post 90Y ibritumomab tiuxetan treatment ]CTT assessment before and after 90Y ibritumomab tiuxetan treatment - Bone marrow aspiration and biopsies in those patients with positive Bone marrows prior to 90Y ibritumomab tiuxetan treatment.
- Minimal residual disease [ Time Frame: For two years post study entry ]Peripheral blood will be assessed every 6 months for the two years from entry into the trial and subjected to PCR analysis for evidence of lymphoma cells with the t(14;18)
- Time to treatment failure [ Time Frame: Two years of the study duration ]Evidence of progression will be assessed every 6 months for two years from study entry clinically and radiologically to determine the date of disease progression
- Overall survival [ Time Frame: two years of study duration ]Survival will be assessed continually throughout the two year study period
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): NCT01446562
|Sunnybrook Health Sciences Centre, Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Neil L Berinstein, MD, FRCP(C)||Sunnybrook Health Sciences Centre, Odette Cancer Centre|