Trial Review

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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
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
Secondary ID [1] 280550 0
None
Universal Trial Number (UTN)
Trial acronym
R-100 ITP study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic thrombocytopaenic purpura 252002 0
Condition category
Condition code
Blood 252194 252194 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 100mg dose of rituximab is given intra-venously weekly for 4 weeks in total
Intervention code [1] 241412 0
Treatment: Drugs
Comparator / control treatment
No control arm
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253074 0
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.
Timepoint [1] 253074 0
Assess at weeks 8,16,26 and 52 and 24 months
Secondary outcome [1] 257916 0
Safety profile and any infection problems by physical examination and clinical questions.
Timepoint [1] 257916 0
Weeks 8, 16, 26 and 52 weeks and also at 24 months

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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged <18 years
ITP diagnosed <8 weeks
Prior Rituximab therapy
HIV infection
SLE associated
Lymphoproliferative associated

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)
Centre ask to enrol patients and we will allott a study number and if inclusion criteria OK we proceed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not relevant
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase II, single arm multi- centre
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2268 0
New Zealand
State/province [1] 2268 0

Funding & Sponsors
Funding source category [1] 285348 0
Charities/Societies/Foundations
Name [1] 285348 0
Florence Peterson Fund
Country [1] 285348 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Florence Peterson Fund
Address
Care of Peter Morpeth
ITM Accounting
60 Tory St
Wellington 6023
Country
New Zealand
Secondary sponsor category [1] 251222 0
None
Name [1] 251222 0
Address [1] 251222 0
Country [1] 251222 0
Other collaborator category [1] 276832 0
Individual
Name [1] 276832 0
Professor John Carter
Address [1] 276832 0
Wellington Clinical School
University of Otago
Private Bag 61
Wellington 6023
Country [1] 276832 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287332 0
Multi-region Ethics Committee
Ethics committee address [1] 287332 0
Courier address:
c/- Ministry of Health
Level 2, Reception
1-3 The Terrace
Wellington
6011
Ethics committee country [1] 287332 0
New Zealand
Date submitted for ethics approval [1] 287332 0
26/01/2009
Approval date [1] 287332 0
20/11/2009
Ethics approval number [1] 287332 0
MEC/09/02/018

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.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 30387 0
Address 30387 0
Country 30387 0
Phone 30387 0
Fax 30387 0
Email 30387 0
Contact person for public queries
Name 13634 0
Dr K R ROMERIL
Address 13634 0
WEllington Blood and Cancer Centre
Wellington Hospital
Riddiford St
Wellington 6023
Country 13634 0
New Zealand
Phone 13634 0
006443855999
Fax 13634 0
006443855814
Email 13634 0
kenneth.romeril@ccdhb.org.nz
Contact person for scientific queries
Name 4562 0
Dr K R ROMERIL
Address 4562 0
Wellington Blood and cancer Centre
Wellington Hospital
Riddiford St
Wellington 6023
Country 4562 0
New Zealand
Phone 4562 0
006443855999
Fax 4562 0
006443855814
Email 4562 0
kenneth.romeril@ccdhb.org.nz

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.