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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12612000591853
Ethics application status
Approved
Date submitted
30/05/2012
Date registered
1/06/2012
Date last updated
1/06/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
The R- 100 ITP Study : evaluating the efficacy of a single weekly dose of 100mg of Rituximab over 4 weeks in patients with refractory or relapsing idiopathic thrombocytopaenic purpura
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Scientific title
A multi-centre,single arm, phase II study to evaluate the efficacy of a single weekly 100mg dose of Rituximab over 4 weeks in patients with refractory or relapsing idiopathic thrombocytopaenic purpura
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Secondary ID [1]
280550
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None
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Universal Trial Number (UTN)
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Trial acronym
R-100 ITP study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic thrombocytopaenic purpura
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Condition category
Condition code
Blood
252194
252194
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0
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Haematological diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A 100mg dose of rituximab is given intra-venously weekly for 4 weeks in total
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Intervention code [1]
241412
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Treatment: Drugs
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Comparator / control treatment
No control arm
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To evaluate the ORR of the Rituximab dose used by physical examination and measuring the platelet count to see if it has responded to the therapy.
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Assessment method [1]
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Timepoint [1]
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Assess at weeks 8,16,26 and 52 and 24 months
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Secondary outcome [1]
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Safety profile and any infection problems by physical examination and clinical questions.
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Assessment method [1]
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Timepoint [1]
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Weeks 8, 16, 26 and 52 weeks and also at 24 months
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Eligibility
Key inclusion criteria
Aged over 18 years
Refractory ITP defined as a platelet count of <30 despite 8 weeks of standard ITP therapy
ITP that has relapsed post splenectomy
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Aged <18 years
ITP diagnosed <8 weeks
Prior Rituximab therapy
HIV infection
SLE associated
Lymphoproliferative associated
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centre ask to enrol patients and we will allott a study number and if inclusion criteria OK we proceed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not relevant
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
Phase II, single arm multi- centre
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/12/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
2268
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Funding & Sponsors
Funding source category [1]
285348
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Charities/Societies/Foundations
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Name [1]
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Florence Peterson Fund
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Address [1]
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Care of Peter Morpeth, Chair of Trustees
ITM Accounting
60 Tory St
Wellington 6023
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Country [1]
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New Zealand
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Primary sponsor type
Charities/Societies/Foundations
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Name
Florence Peterson Fund
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Address
Care of Peter Morpeth
ITM Accounting
60 Tory St
Wellington 6023
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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Individual
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Name [1]
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Professor John Carter
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Address [1]
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Wellington Clinical School
University of Otago
Private Bag 61
Wellington 6023
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Country [1]
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Multi-region Ethics Committee
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Ethics committee address [1]
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Courier address:
c/- Ministry of Health
Level 2, Reception
1-3 The Terrace
Wellington
6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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26/01/2009
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Approval date [1]
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20/11/2009
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Ethics approval number [1]
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MEC/09/02/018
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Summary
Brief summary
Patients with ITP have reduced numbers of platelets in their blood, which makes them at risk of bleeding, which may be severe. The reduced platelets are due to them being destroyed by the patient’s own immune system (autoimmune). Treatment of this usually involves the use of broadly acting drugs to reduce this immune reaction. Drugs such as prednisone are often effective but have significant side effects. A new class of drug provides more targeted treatment with fewer side effects. The drug rituximab was developed to treat patients with cancer of the cells of the immune system and the dose used is high.
This trial uses rituximab, which has been shown to be effective at high dose, in a lower dose schedule. There is some data to suggest that the lower dose may be sufficient and this study seeks to confirm this by treating a statistically sufficient numbers of patients to draw firm conclusions. Patients eligible for the study will have severe ITP which has not responded satisfactorily to standard therapy. Assuming the results of the lower dose are satisfactory the benefits of therapy being cheaper, and the risk of side effects being reduced, would make this treatment an advance in the care of patients with ITP.
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Trial website
none
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Trial related presentations / publications
none
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Public notes
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Contacts
Principal investigator
Name
30387
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Address
30387
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Country
30387
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Phone
30387
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Fax
30387
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Email
30387
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Contact person for public queries
Name
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Dr K R ROMERIL
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Address
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WEllington Blood and Cancer Centre
Wellington Hospital
Riddiford St
Wellington 6023
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Country
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New Zealand
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Phone
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006443855999
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Fax
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006443855814
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr K R ROMERIL
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Address
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Wellington Blood and cancer Centre
Wellington Hospital
Riddiford St
Wellington 6023
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Country
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New Zealand
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Phone
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006443855999
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Fax
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006443855814
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Email
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[email protected]
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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.
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