Follicular Lymphoma Clinical Trial
Official title:
A Phase II, Open-Label, Prospective, Multicenter Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) Study in Patients With Follicular Grade I-II Lymphoma After 4 Cycles of Fludarabine-Mitoxantrone-Rituximab (FMR) Therapy.
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.
Indication: stage II-IV follicular lymphoma (FL) grade I-II after 4 cycles of FMR Study
objectives: Evaluation of efficacy and safety of [90Y]-ibritumomab tiuxetan, as well as
assessment of quality of life Patient population: Patients with after 4 cycles of treatment
with FMR Study design: Prospective, multicenter, open-label study designed to treat patients
with a sequential front-line treatment represented by 4 cycles FMR plus Zevalin Duration of
treatment: Four months for FMR 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
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: 4 study centers in Italy T otal number of
patients, statistical rationale provided: Expected total of 55 patients. The final sample
size will be 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: 3rd quarter 2006. End of
recruitment: 1st quarter of 2007
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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