RecruitingPhase 2ACTRN12607000153415

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


Sponsor

Fremantle Hospital

Enrollment

100 participants

Start Date

Feb 15, 2007

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people newly diagnosed with a slow-growing type of non-Hodgkin's lymphoma (a cancer of the lymph system). It tests a treatment called radioimmunotherapy using a radioactive antibody called I-131 rituximab, followed by further doses of the same antibody without the radioactive tag. This avoids the need for standard chemotherapy, which can cause significant side effects. Previous studies suggest this approach can achieve high rates of complete remission with fewer toxic effects. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with a low-grade or follicular B-cell non-Hodgkin's lymphoma (confirmed by biopsy) - Your lymphoma is at Stage IIB, III, or IV - You have not previously received chemotherapy, radiotherapy, or immunotherapy for lymphoma - Your general health and organ function are within required levels - You can attend the treatment centre for follow-up You may NOT be eligible if: - You are pregnant, breastfeeding, or sexually active without effective contraception (if you are a woman of childbearing age) - Your lymphoma has spread to the brain or spinal cord - Your blood counts or organ function are below required levels - You have significant heart, kidney, or liver disease - You have another active cancer (within the last 5 years, with some exceptions) - You are on long-term steroid treatment for any condition Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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:

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)

Australia

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ACTRN12607000153415