INTIAL STUDY - Indolent Non-Hodgkin's ImmunoradioTherapy Initiated Approach in Lymphoma
Phase II observational study of the effect of I-131 anti-CD20 antibody (rituximab)radioimmunotherapy on overall and disease-free survival in patients with newly diagnosed low-grade non-Hodgkins lymphoma
Fremantle Hospital
100 participants
Feb 15, 2007
Interventional
Conditions
Summary
This study will evaluate the use of I-131 rituximab radioimmunotherapy, together with further doses of unlabelled rituximab immunotherapy, as treatment for advanced stage follicular and low-grade non-Hodgkins lymphoma. Such patients are currently recommended for treatment with systemic chemotherapy and unlabelled rituximab. Many patients are anxious to avoid the toxicity associated with systemic chemotherapy. We have previously demonstrated that I-131 rituximab (as used at Fremantle Hospital) has equivalent efficacy to the licensed agents (I-131 tositumomab and Y-90 ibritumomab) approved for use in the United States in patients with relapsed or refractory non-Hodgkins lymphoma. We expect, therefore, similar efficacy to these agents in patients with newly diagnosed lymphoma Previous North American research has shown that I-131 radioimmunotherapy can achieve response rates similar to those seen with chemotherapy in patients with newly diagnosed non-Hodgkins lymphoma. These investigators used I-131 tositumomab (Bexxar®), a similar product to I-131 rituximab, and achieved an overall response rate of 95%. 75% patients showed a complete remission and, of these, 70% remained in remission for 5 years or more. The 5-year progression-free survival was 60%.
Eligibility
Plain Language Summary
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Interventions
Intravenous administration of radiolabelled Rituximab in one tracer and one therapy activity followed by maintenance treatment with MabThera over one year. Intervention: Week one: Intravenous (IV) rituximab 375 mg/m2 dosimetry using tracer dose of IV I-131 rituximab Week two: IV rituximab 375 mg/m2 therapy with individualised dose of IV I-131 rituximab. The therapeutic dose of I-131 rituximab is individualised for each patient, according to their clearance of a tracer quantity of I-131 rituximab. The therapeutic dose is calculated to give an absorbed dose to the red marrow of < 0.75 Gy. Week three: IV rituximab 375 mg/m2 Week four: IV rituximab 375 mg/m2 Three months: IV rituximab 375 mg/m2 six months: IV rituximab 375 mg/m2 Nine months: IV rituximab 375 mg/m2 Twelve months: IV rituximab 375 mg/m2
Locations(1)
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ACTRN12607000153415