Use of Tocilizumab (TCZ) to prevent acute graft versus host disease (GVHD)
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)
Royal Brisbane and Women's Hospital
48 participants
Jan 13, 2012
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria1
- 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.
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Interventions
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.
Locations(1)
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ACTRN12612000726853