Trial Review

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Trial registered on ANZCTR


Registration number
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
Sex
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
9/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
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
Country [1] 426 0
Australia
Funding source category [2] 427 0
Commercial sector/Industry
Name [2] 427 0
Roche
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
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
[email protected]
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
[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
No additional documents have been identified.