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Trial registered on ANZCTR


Trial ID
ACTRN12605000236695
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
26/08/2005
Date last updated
26/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase II single centre study assessing the efficacy and safety of I-131 rituximab radioimmunotherapy of relapsed or refractory diffuse large B cell lymphoma.
Scientific title
Phase II single centre study assessing the efficacy and safety of I-131 rituximab radioimmunotherapy of relapsed or refractory, CD 20 positive, diffuse large B cell lymphoma, with the primary objective tumour response.
Secondary ID [1] 125 0
ML 18983
Universal Trial Number (UTN)
Trial acronym
RITRAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse large B cell lymphoma 322 0
Condition category
Condition code
Cancer 368 368 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
I-131 rituximab administered as tracer dosimetry and a therapeutic dose followed by consolidation and maintenance unlabelled rituximab, 2 monthly for one year.
Intervention code [1] 269 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 429 0
Objective tumour response
Timepoint [1] 429 0
Measured at 6, 12 and 24 weeks and at 1 year post treatment, then as clinically indicated.
Secondary outcome [1] 924 0
Tolerability and safety of treatment
Timepoint [1] 924 0
Secondary outcome [2] 925 0
Duration of response
Timepoint [2] 925 0
Secondary outcome [3] 926 0
Time to treatment failure
Timepoint [3] 926 0
Secondary outcome [4] 927 0
Time to disease progression
Timepoint [4] 927 0
Secondary outcome [5] 928 0
Overall survival
Timepoint [5] 928 0
Secondary outcome [6] 929 0
Quality of life
Timepoint [6] 929 0

Eligibility
Key inclusion criteria
Histologically proven CD 20 positive diffuse large B cell lymphoma, previously treated with a chemotherapy regimen with or without rituximab in patients who have relapsed or are refractory; with a minimum life expectancy of 3 months.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-exisiting myelodysplasia.

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
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 426 0
Hospital
Name [1] 426 0
Fremantle Hospital & Health Service
Address [1] 426 0
Country [1] 426 0
Australia
Funding source category [2] 427 0
Commercial sector/Industry
Name [2] 427 0
Roche
Address [2] 427 0
Country [2] 427 0
Primary sponsor type
Hospital
Name
Fremantle Hospital & Health Service
Address
Country
Australia
Secondary sponsor category [1] 345 0
Commercial sector/Industry
Name [1] 345 0
Roche Australia
Address [1] 345 0
Country [1] 345 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1397 0
Fremantle Hospital & Health Service (single centre)
Ethics committee address [1] 1397 0
Ethics committee country [1] 1397 0
Australia
Date submitted for ethics approval [1] 1397 0
Approval date [1] 1397 0
Ethics approval number [1] 1397 0

Summary
Brief summary
To evaluate the efficacy and the safety of I-131 rituximab in relapsed large B cell lymphoma administered as induction treatment and followed by standard non-radioactive rituximab as consolidation and maintenance treatment for one year in 40 patients in a single centre phase II open-label non-randomised study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36378 0
Address 36378 0
Country 36378 0
Phone 36378 0
Fax 36378 0
Email 36378 0
Contact person for public queries
Name 9458 0
Professor J. Harvey Turner
Address 9458 0
Department of Nuclear Medicine
Fremantle Hospital
Alma Street
Fremantle WA 6160
Country 9458 0
Australia
Phone 9458 0
+61 8 94312888
Fax 9458 0
+61 8 94312889
Email 9458 0
Harvey.Turner@health.wa.gov.au
Contact person for scientific queries
Name 386 0
Professor J. Harvey Turner
Address 386 0
Department of Nuclear Medicine
Fremantle Hospital
Alma Street
Fremantle WA 6160
Country 386 0
Australia
Phone 386 0
+61 8 94312888
Fax 386 0
+61 8 94312889
Email 386 0
Harvey.Turner@health.wa.gov.au