Use of Tocilizumab (TCZ) to prevent acute graft versus host disease (GVHD)

A phase II study of humanized anti-IL-6 receptor antibody Tocilizumab (TCZ) to prevent development of acute graft versus host disease (GVHD) post Human Leuckocyte Antigen(HLA)-mismatched allogeneic haematopoietic progenitor cell transplantation (HPCT)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000212651

Enrollment

Registered

2014-02-27

Start date

2014-04-04

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). You may be eligible to join this study if you are aged between 18 and 65 and are undertaking an HLA-mismatched allogeneic haematopoietic cell transplantation (HPCT). Trial details all participants inthis 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-mismatched allogeneic HPCT using either myeloablative or reduced intensity conditioning Aged greater than or equal to 18 and less than 65 years Life expectancy of greater than 3 months Eastern Cooperative Oncology Group (ECOG) performance status less than 2 (Karnofsky greater than 50%) Adequate organ function for allogeneic stem cell transplantation as per Institutional guidelines 1 or 2 Antigen HLA-mismatched sibling donor by typing at HLA-A, B, C and DRB1 and DQ loci. Only 1 antigen mismatch is allowed at HLA-A, B, C or DRB1, with / without a further mismatch at HLA-DQ. 1 or 2 HLA- matched volunteer unrelated donor (VUD) by typing at HLA-A, B, C, DRB1 and DQ loci. Only 1 antigen mismatch is allowed at HLA-A, B, C or DRB1, with / without a further mismatch at HLA-DQ. Able and willing to provide written informed consent

Exclusion criteria

Inadequate organ function for allogeneic stem cell transplantation as per Institutional guidelines. 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 or active HBV infection. Patients who are HepBcAb positive but HepBsAg negative (i.e. have had past HepB exposure) should receive lamivudine up to at least day 100 after HPCT. Pregnant or breastfeeding, or patient with reproductive potential who is not willing to use adequate contraceptive precautions in the judgement of the Investigator. Adequate contraception is defined as a double-barrier method, i.e. using at least 2 methods of contraception e.g. 2 actual barrier methods or 1 actual barrier method and 1 hormonal method. 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 composition as TCZ, including known allergies to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.

Outcome results