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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 22 February 2013
Main ID:  ACTRN12607000153415
Date of registration: 02/03/2007
Primary sponsor: Hospital Fremantle Hospital
Public title: INTIAL STUDY - Indolent Non-Hodgkin's ImmunoradioTherapy Initiated Approach in Lymphoma INITIAL
Scientific title: 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
Date of first enrolment: 15/02/2007
Target sample size: 100
Recruitment status: Recruiting
URL:  http://www.anzctr.org.au/ACTRN12607000153415.aspx
Study type:  Interventional
Study design:  Nonrandomised trial  Single group
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
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.

Age minimum: 18 Years
Age maximum: 0 Not stated
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Advanced stage follicular and low-grade non-Hodgkin's lymphoma
Intervention(s)
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
Primary Outcome(s)
Disease-free survival
Overall survival
Secondary Outcome(s)
Quality of life
Relapse or censoring
Secondary ID(s)
Source(s) of Monetary Support
Fremantle Hospital and Health Service
Secondary Sponsor(s)
N/A
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