None listed
Conditions
Brief 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%.
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, accor
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
Sponsors
Fremantle Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. CD20-positive, low-grade indolent and follicular B cell non-Hodgkin lymphoma of the following histological types4 manifested as measurable disease: a. Stage IIB, III and IV follicular centre cell lymphoma.Grade I Grade 2 b. Lymphoplasmacytoid lymphomac. Marginal zone lymphomad. Extranodal MALT lymphomae. Circulating splenic lymphoma (SLVL)All patients must have a tissue biopsy confirming low-grade disease and CD20 expression within 12 months prior to study entry or bone marrow biopsy confirming CD20-positive low-grade lymphoma, plus evidence of the same disease process within an area of measurable disease as confirmed on fine needle aspiration or core biopsy. 2. No prior chemotherapy, radiotherapy or immunotherapy for lymphoma. 3. ECOG Performance Status 0 – 2 4. Life expectancy > 3 months. 5. Ability to give informed consent. 6. Accessibility to treatment centre for follow up.
Exclusion criteria
1. Pregnant or lactating women, or sexually active women of childbearing age without effective contraception.2. Evidence of lymphoma involvement of central nervous system or spinal cord compression.3. Inadequate haemopoietic function, defined as;(i) neutrophils < 1.0 x 109 /L, or(ii) platelets < 70 x 109/L(iii) haemoglobin< 100 g/L (unless due to iron deficiency)4. Any prior therapy for lymphoma.5. Significant coexisting morbidities.(i) heart failure (NYHA class III – IV)(ii) renal impairment (serum creatinine > 150 micromol/L) (iii) liver failure. bilirubin > 30 micromol/L. alkaline phosphatase (ALP) > 4 times upper limit of normal (ULN)ALT > 4 times ULN(iv) any coexistent disease requiring oral steroid treatment.(v) neurologic or psychiatric disease.(vi) concomitant malignancy in past 5 years with the exception of a cured carcinoma of the cervix or non-melanoma skin cancer.
Outcome results
None listed