RecruitingPhase 2ACTRN12614000212651

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)


Sponsor

Royal Brisbane and Women's Hospital

Enrollment

18 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). 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.


Eligibility

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called Tocilizumab can help prevent a serious complication called graft versus host disease (GVHD) in people receiving a stem cell transplant. GVHD happens when donor immune cells attack the recipient's body. Participants will receive a single dose of Tocilizumab one day before their transplant, and researchers will follow them for up to 2 years. You may be eligible if: - You are between 18 and 65 years old - You are having an HLA-mismatched stem cell (bone marrow) transplant - Your organ function is adequate for transplant - Your ECOG performance status is less than 2 (you are able to carry out basic activities) - You have a life expectancy of more than 3 months - You are able to give written informed consent You may NOT be eligible if: - You are pregnant or breastfeeding - You have HIV, hepatitis C, or active hepatitis B infection - You have had a solid tumour diagnosis within the past 2 years (other than certain treated skin cancers) - You have had complicated diverticulitis, bowel perforation, or fistula - You have an uncontrolled infection or serious heart condition - You are allergic to Tocilizumab or similar biological 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)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

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