RecruitingPhase 3ACTRN12614000266662

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

A phase III randomized 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)-matched allogeneic haematopoietic progenitor cell transplantation (HPCT)


Sponsor

Royal Brisbane and Women's Hospital

Enrollment

110 participants

Start Date

Apr 4, 2014

Study Type

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 70 years of age and are undertaking HLA-matched allogeneic haematopoietic cell transplantation (HPCT). Trial details: Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group 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 in the second study group will receive a placebo treatment. Participants will be assessed for up to 2 years to determine the incidence of GVHD.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving one dose of the drug Tocilizumab one day before a stem cell transplant can safely and effectively prevent a serious complication called graft versus host disease (GVHD). GVHD occurs when the transplanted donor cells attack the patient's body. This is a randomised trial, meaning some participants will receive Tocilizumab and others will receive a placebo (inactive treatment). You may be eligible if: - You are between 18 and 70 years old - You have acute leukaemia in remission or myelodysplasia - You are having a stem cell transplant from a matched donor (related or unrelated) - Your organ function is adequate for transplant - Your ECOG performance status is 2 or below - You have a life expectancy of more than 3 months You may NOT be eligible if: - You are pregnant or breastfeeding - You have HIV, hepatitis C, or active hepatitis B - You have had a solid tumour (other than certain treated skin cancers) within the past 2 years - You have an active serious infection or unstable heart condition - You have a history of bowel perforation or complicated diverticulitis - You have liver cirrhosis - You are allergic to Tocilizumab or similar medicines - Your donor is an identical twin Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

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)

NSW,QLD,VIC, Australia

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