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 information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000726853
Ethics application status
Approved
Date submitted
18/06/2012
Date registered
6/07/2012
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of Tocilizumab (TCZ) to prevent acute graft versus host disease (GVHD)
Scientific title
A phase I/II study of humanized anti-IL-6 receptor antibody Tocilizumab (TCZ) to prevent development of acute graft versus host disease (GVHD) post HLA-matched allogeneic haematopoietic cell transplantation (HPCT)
Secondary ID [1] 280198 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute graft versus host disease (GVHD) post HLA-matched allogeneic haematopoietic progenitor cell transplantation (HPCT) 285917 0
Condition category
Condition code
Cancer 286107 286107 0 0
Leukaemia - Acute leukaemia
Cancer 287161 287161 0 0
Leukaemia - Chronic leukaemia
Cancer 287171 287171 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tocilizumab dose of 8mg/kg up to a maximum dose of 800mg to be administered as a single dose only. Tocilizumab is administered as an intravenous infusion over 60 minutes on day -1 of conditioning.
Intervention code [1] 284331 0
Prevention
Comparator / control treatment
this study is uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286583 0
Incidence of grade II-IV (moderate - severe) acute GVHD
Timepoint [1] 286583 0
Day + 100 post HLA-matched allogeneic haematopoietic progenitor cell transplantation (HPCT)
Secondary outcome [1] 298183 0
Il-6/IL-6R and Tocilizumab levels post-HPCT assessed by serum assay
Timepoint [1] 298183 0
2 years post HLA-matched allogeneic HPCT
Secondary outcome [2] 298184 0
Effector and regulatory T cell subsets post-HPCT assessed by flow cytometry
Timepoint [2] 298184 0
2 years post HLA-matched allogeneic HPCT
Secondary outcome [3] 298185 0
Incidence of engraftment/infection rate/liver toxicity by medical assessment and blood testing
Timepoint [3] 298185 0
2 years post HLA-matched allogeneic HPCT

Eligibility
Key inclusion criteria
Patients undertaking a T cell-replete HLA-matched allogeneic HPCT using either myeloblative or reduced intensity conditioning, life expectancy of greater than 3 months, ECOG < 2, Total bilirubin less than 30, Serum transaminases (AST/ALT) less than 3.0 x ULN, creatinine clearance greater than or equal to 50mL/min/1.73m^2, LVEF greater than or equal to 40 %, Pulmonary diffusion capacity greater than or equal to 40 %, HLA-matched sibling donor or HLA-matched volunteer unrelated donor.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving any other investigational agents, patients with a past history of solid tumours within prior 2 years (excluding completely excised cutaneous BCC and SCC), uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, known HIV, HCV and HBV infection, pregnant or breastfeeding, or patient with reproductive potential who is not willing to use adequate contraceptive precautions in the judgement of the Investigator, patients with a past history of complicated diverticulitis, including fistulae, abscess formation or gastrointestinal (GI) perforation, donor is an identical twin (i.e. syngeneic), history of allergic reactions attributed to compounds of similar chemical or biologic compositions as TCZ, including known allergies to Chinese hamster ovary cell products or other recombinant human or humanised antibodies.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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)
QLD

Funding & Sponsors
Funding source category [1] 285432 0
Government body
Name [1] 285432 0
National Health & Medical Research Council
Address [1] 285432 0
GPO Box 1421
Canberra
ACT 2601
Country [1] 285432 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 284284 0
Other
Name [1] 284284 0
Queensland Institute of Medical Research
Address [1] 284284 0
Clive Berghofer Cancer Research Centre
300 Herston Road
Herston
Brisbane
QLD 4006
Country [1] 284284 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287441 0
Royal Brisbane and Women's Human Research Ethics Committee
Ethics committee address [1] 287441 0
Level 7 Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
QLD 4029
Ethics committee country [1] 287441 0
Australia
Date submitted for ethics approval [1] 287441 0
Approval date [1] 287441 0
26/10/2011
Ethics approval number [1] 287441 0
HREC/11/QRBW/345

Summary
Brief summary
This study aims to determine whether adding the drug, Tocilizumab, to standard transplant immunosuppression is safe and effective at preventing acute graft versus host disease (GVHD).
Who is it for?
You may be eligible to join this study if you are aged between 18 and 65 years of age and are undertaking an HLA-matched allogeneic haematopoietic cell transplantation (HPCT).
Trial details
All participants in this trial will receive a single dose of 8mg/kg Tocilizumab by a 60 minute intravenous infusion (administered via the vein). This will occur one day before your HPCT.
Participants will be assessed for up to 2 years to determine the incidence of GVHD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33822 0
Address 33822 0
Country 33822 0
Phone 33822 0
Fax 33822 0
Email 33822 0
Contact person for public queries
Name 17069 0
A/Prof Glen Kennedy
Address 17069 0
Royal Brisbane and Women's Hospital
Cancer Care Services
Level 5 Joyce Tweddell Building
Herston
QLD 4029
Country 17069 0
Australia
Phone 17069 0
+61 7 3646 1340
Fax 17069 0
+61 7 3646 7371
Email 17069 0
Glen_Kennedy@health.qld.gov.au
Contact person for scientific queries
Name 7997 0
Prof Geoff Hill
Address 7997 0
Clive Berghofer Cancer Research Centre
300 Herston Road
Herston
Brisbane
QLD 4006
Country 7997 0
Australia
Phone 7997 0
+61 7 3845 3763
Fax 7997 0
+61 7 3845 3509
Email 7997 0
Geoff.Hill@qimr.edu.au

No information has been provided regarding IPD availability
Summary results
No Results