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Trial registered on ANZCTR


Registration number
ACTRN12607000628448
Ethics application status
Approved
Date submitted
6/12/2007
Date registered
10/12/2007
Date last updated
16/01/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of combining rituximab and low-dose (1.0Gy) total nodal irradiation in treatment of extensive chronic graft-versus-host disease
Scientific title
A pilot study of combining rituximab and low-dose (1.0Gy) total nodal irradiation in treatment of extensive chronic graft-versus-host disease
Universal Trial Number (UTN)
Trial acronym
R-TNI study in cGVHD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic graft-versus-host disease (GVHD) 2608 0
Condition category
Condition code
Blood 2726 2726 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose of 1000mg iv Rituximab (given on Day 1) combined with low-dose (1.0 Gy) total nodal irradiation (given only on Day 8). GVHD assessment at 3 months: if chronic GVHD improves, proceed to receive maintenance rituximab (500mg iv) 3 monthly x 4
Intervention code [1] 2347 0
Treatment: Drugs
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3619 0
safety and tolerability: measured by clinical assessment ( evidence of infection); full blood examination (cytopenias); biochemistry and liver enzyme tests (for organ toxicity); reactivation of cytomegalovirus (CMV) by serial CMV antigen by PCR testing in first 2 months
Timepoint [1] 3619 0
at 3 months after single dose of 1000mg of rituximab and single dose of 1.0Gy of total nodal irradiation
Secondary outcome [1] 6060 0
response rate: measured by (1) total dose reduction in systemic immunosuppression (for example: complete remission if off all immunosuppression by 3 months); (2)detail clinical examination; (3) repeat skin biopsy for histological assessment;
Timepoint [1] 6060 0
at 3, 6, 12, 24 months

Eligibility
Key inclusion criteria
active, extensive cutaneous chronic GVHD with suboptimal response to standard systemic immunosuppression
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Chronic GVHD with irreversible end-organ damage (2) uncontrolled infection (3)
Severe cytopenias

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
Recruiting
Date of first participant enrolment
Anticipated
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2867 0
Commercial sector/Industry
Name [1] 2867 0
Roche Products Pty Ltd
Country [1] 2867 0
Australia
Primary sponsor type
Individual
Name
Simon He and Andrew Grigg
Address
The Royal Melbourne Hospital
Grattan Street, Parkville, Victoria 3050
Country
Australia
Secondary sponsor category [1] 2583 0
None
Name [1] 2583 0
Address [1] 2583 0
Country [1] 2583 0
Australia
Secondary sponsor category [2] 2584 0
None
Name [2] 2584 0
n/a
Address [2] 2584 0
n/a
Country [2] 2584 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4805 0
Ethics committee address [1] 4805 0
Ethics committee country [1] 4805 0
Date submitted for ethics approval [1] 4805 0
15/10/2007
Approval date [1] 4805 0
Ethics approval number [1] 4805 0
Ethics committee name [2] 4806 0
Ethics committee address [2] 4806 0
Ethics committee country [2] 4806 0
Date submitted for ethics approval [2] 4806 0
15/10/2007
Approval date [2] 4806 0
Ethics approval number [2] 4806 0
HREC 2007.251

Summary
Brief summary
Chronic graft-versus-host disease (cGVHD) is a significant complication for many patients who survive an allogeneic bone marrow transplantation for haematological maligancy. A number of patients with extensive cGVHD have suboptimal control despite adequate steroid-based therapy with other immunosuppression such as cyclosporin. There is no standard salvage treatment to effectively control the disease and avoid long-term toxicity of steroids. This is the first prospective pilot study to explore the use of a single-dose of rituximab plus Low-dose total nodal irradiation (TNI) in the treatment of cGVHD involving the skin and other organ(s). There are a growing body of retrospective data regarding the effectiveness of rituximab and TNI respectively for the treatment of cGVHD. The hypothesis in this pilot study is that the combined treatment approach is safe and effective in treating extensive cGVHD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28231 0
Address 28231 0
Country 28231 0
Phone 28231 0
Fax 28231 0
Email 28231 0
Contact person for public queries
Name 11388 0
Simon He
Address 11388 0
The Royal Melbourne Hospital
Grattan Street, Parkville, 3050 Victoria
Country 11388 0
Australia
Phone 11388 0
+61393428410
Fax 11388 0
Email 11388 0
[email protected]
Contact person for scientific queries
Name 2316 0
Simon He
Address 2316 0
The Royal Melbourne Hospital
Grattan Street, Parkville, 3050 Victoria
Country 2316 0
Australia
Phone 2316 0
+61393428410
Fax 2316 0
Email 2316 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
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