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CompletedLast updated: 22 January 2024

NC96: This phase III trial is evaluating tocilizumab (an immunosuppressant) as a way of preventing acute graft versus host disease (GVHD) in patients with Acute LeukaemiaA 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)

Clinical summary

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.

Conditions

This trial is treating patients with Graft versus Host disease.

Cancer

Blood Cancers Haematological

Age

People18 - 70

Phase

III

Trial Acronym

NC96

More information

Trial Identifiers

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Trial sponsor

Royal Brisbane and Womens Hospital

Scientific Title

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)

Eligibility

Inclusion

Patients undertaking a T cell-replete HLA-matched allogeneic HPCT using either myeloablative or reduced intensity conditioning
Acute leukaemia in complete morphological remission or myelodysplasia
Aged greater than or equal to 18 and less than 70 years
Life expectancy of greater than 3 months
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 50%)
Adequate organ function for allogeneic stem cell transplantation as per Institutional guidelines.
HLA-matched sibling donor by typing at HLA-A, B, C and DRB1 loci.
HLA- matched volunteer unrelated donor (VUD) by typing at HLA-A, B, C, DRB1 loci)
Able and willing to provide written informed consent

Exclusion

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)
Known hepatic cirrhosis
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.

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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