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Study phase: Phase II Investigational product, dosage, and route of administration: Ibritumomab tiuxetan ("Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan. To prepare the active therapeutic agent [90Y]-ibritumomab tiuxetan, the antibody is chelated with the β-emitter yttrium-90 chloride immediately before intravenous administration. Treatment with [90Y]-ibritumomab tiuxetan is preceded by an infusion of rituximab (Rituxan, Mabthera) in order to optimize the biodistribution of radiolabeled antibody by depleting CD20 positive B-cells. Rituximab is a chimeric human/murine IgG1 monoclonal antibody. The Zevalin study regimen is given as an infusion of rituximab 250 mg/m2 and (where biodistribution imaging or dosimetry is compulsory) 185 MBq (5mCi) of [111In]-ibritumomab tiuxetan on Day 1 followed 7 to 9 days later by a single dose of 14.8 MBq/kg (0.4 mCi/kg) of [90Y]-ibritumomab tiuxetan, maximal dose of 1184 MBq (32 mCi), preceded by 250 mg/m2 of rituximab.
Reference product, dosage, and route of administration: Not applicable Indication: stage II-IV diffuse large B-cell lymphoma (DLBCL) patients after 4 cycles of CHOP21-Rituximab (CHOP21-R) Study objectives: Evaluation of efficacy and safety of [90Y]-ibritumomab tiuxetan, as well as assessment of quality of life Patient population: Patients more than 60 years-of-age with DLBCL after 4 cycles of treatment with CHOP21-R Study design: Prospective, multicenter, open-label study designed to treat patients with a sequential front-line treatment represented by: 4 cycles CHOP21-R plus Zevalin Duration of treatment: Four months for CHOP21-R and two treatment days one week apart followed by a 12-week safety period for Zevalin Duration of study: Estimated duration of study is 18 months Methodology: Primary efficacy parameter: Overall response rate and complete response rate. Secondary efficacy parameters: Overall survival, disease-free survival, health-related quality of life. Safety parameters: Vital signs, adverse events (AEs), hematology, blood chemistry, and immunoglobulin levels Number of study centers: Planned total of 10 study centers in Italy Total number of patients, statistical rationale provided: Expected total of approximately 55 patients. The final sample size is based on the number of events observed for the primary efficacy endpoint as calculated in the sequential statistical model. Adverse events: AEs observed, mentioned upon open questioning and/or spontaneously reported will be documented.
Planned start and end of recruitment: Start of recruitment: 19/12/2006. End of recruitment: 04/11/2008.
Manufacturer(s) of the investigational /reference product(s): Ibritumomab tiuxetan is manufactured by Biogen IDEC, San Diego, CA and Cambridge, MA, USA. The isotopes yttrium-90 will be provided by European suppliers. There is no reference product in this study.
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Diffuse Large B-Cell Lymphoma
Istituto di Ematologia e Oncologia Medica Seràgnoli
University of Bologna
Published on BioPortfolio: 2014-08-27T03:24:03-0400
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