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Trial registered on ANZCTR


Registration number
ACTRN12607000153415
Ethics application status
Approved
Date submitted
15/02/2007
Date registered
2/03/2007
Date last updated
2/03/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
INTIAL STUDY - Indolent Non-Hodgkin's ImmunoradioTherapy Initiated Approach in Lymphoma
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
Universal Trial Number (UTN)
Trial acronym
INITIAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced stage follicular and low-grade non-Hodgkin's lymphoma 1653 0
Condition category
Condition code
Cancer 1759 1759 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 1605 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2456 0
Overall survival
Timepoint [1] 2456 0
Measured at 3 months, 12 months and at least annually for minimum of 5 years. Patients followed until death, relapse or censoring at 5 years
Primary outcome [2] 2457 0
Disease-free survival
Timepoint [2] 2457 0
Measured at 3 months, 12 months and at least annually for minimum of 5 years. Patients followed until death, relapse or censoring at 5 years
Secondary outcome [1] 4222 0
Quality of life
Timepoint [1] 4222 0
Measured at same time points at 3 months, 12 months and at least annually for minimum of 5 years patients followed until death.
Secondary outcome [2] 4223 0
Relapse or censoring
Timepoint [2] 4223 0
At 5 years.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase II
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1912 0
Government body
Name [1] 1912 0
Fremantle Hospital and Health Service
Country [1] 1912 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital
Address
Country
Australia
Secondary sponsor category [1] 1724 0
None
Name [1] 1724 0
N/A
Address [1] 1724 0
Country [1] 1724 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3556 0
Fremantle Hospital
Ethics committee address [1] 3556 0
Ethics committee country [1] 3556 0
Australia
Date submitted for ethics approval [1] 3556 0
Approval date [1] 3556 0
13/02/2007
Ethics approval number [1] 3556 0
07/2

Summary
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%.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27539 0
Address 27539 0
Country 27539 0
Phone 27539 0
Fax 27539 0
Email 27539 0
Contact person for public queries
Name 10794 0
Ms. Jenny Lavin
Address 10794 0
Department of Nuclear Medicine
Fremantle Hospital, Alma St, Fremantle WA 6160
Country 10794 0
Australia
Phone 10794 0
(08) 9431 2888
Fax 10794 0
(08) 9431 2889
Email 10794 0
[email protected]
Contact person for scientific queries
Name 1722 0
Dr. William B.G. Macdonald
Address 1722 0
Department of Nuclear Medicine
Fremantle Hospital, Alma St, Fremantle WA 6160
Country 1722 0
Australia
Phone 1722 0
(08) 9431 2888
Fax 1722 0
(08) 9431 2889
Email 1722 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLong-term efficacy and safety of chemotherapy-free first-line iodine-131-rituximab radioimmunotherapy of follicular lymphoma.2022https://dx.doi.org/10.1111/bjh.17758
N.B. These documents automatically identified may not have been verified by the study sponsor.