RecruitingPhase 2ACTRN12612000726853

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)


Sponsor

Royal Brisbane and Women's Hospital

Enrollment

48 participants

Start Date

Jan 13, 2012

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 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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a single dose of tocilizumab (a drug that reduces immune activity) before a stem cell transplant can prevent graft-versus-host disease (GVHD). GVHD is a serious complication where the donor's immune cells attack the transplant recipient's body. Tocilizumab blocks a specific inflammatory signal and may reduce this reaction. You may be eligible if: - You are 18 to 65 years old - You are having a matched stem cell transplant (from a matched sibling or unrelated donor) - Your general health is good enough for transplant (ECOG score below 2) - Your heart, lungs, liver, and kidneys are functioning adequately You may NOT be eligible if: - You have had a solid tumor in the last 2 years (skin cancers are acceptable) - You are HIV, hepatitis B, or hepatitis C positive - You are pregnant or breastfeeding - You have had serious bowel complications such as diverticulitis with abscess - You have allergies to similar biologic medications 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)

QLD, Australia

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