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)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000726853

Enrollment

Registered

2012-07-06

Start date

2012-01-13

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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.

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.

Outcome results