RecruitingPhase 2NCT06510699

Pharmacogenomics for Better Treatment of Fungal Infections in Cancer

Randomized Clinical Trial to Evaluate the Use of Genotype-based Dosing of Voriconazole in Patients With Haematological Malignancy


Sponsor

The University of Queensland

Enrollment

104 participants

Start Date

Apr 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This project aims to address invasive fungal infections in patients with blood cancer, by precision dosing of voriconazole based on CYP2C19 genotype testing with Bayesian dose-forecasting dosing software to develop patient-centric and maximally effective dosing regimens. This study investigates if voriconazole increases the proportion of patients achieving therapeutic exposure at day 8 of dosing compared with standard care; and will assess factors that influence the implementation of genotype testing and dosing software in the healthcare system, including fidelity, feasibility, acceptability and cost-effectiveness. It will recruit at least 104 kids and adults in a parallel-group randomised clinical trial. A hybrid feasibility sub-study will assess the scalability of genotype-directed dosing to ensure sustainable integration of the interventions into the clinical workflow. A health economic sub-study will evaluate the costs, health outcomes and cost-effectiveness of genotype-directed testing compared to standard care.


Eligibility

Min Age: 2 Years

Inclusion Criteria5

  • Age ≥ 2 years.
  • Written informed consent obtained.
  • Decision to prescribe voriconazole.
  • Diagnosed with haematological malignancy or disorder.
  • Admitted to a trial site, or sufficient outpatient follow-up appointments are feasible

Exclusion Criteria3

  • Post-allogeneic haematopoietic stem cell transplant (HCT) patient, without access to pre HCT DNA
  • Death is likely imminent within 7 days.
  • Previously randomised to this trial

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Interventions

OTHERgenotype-directed dosing with dosing software based on therapeutic drug monitoring

Genotype-directed dosing with dosing software based on therapeutic drug monitoring


Locations(7)

Fred Hutchinson Cancer Centre

Seattle, Washington, United States

Sydney Children's Hospital Network

Sydney, New South Wales, Australia

Westmead Hospital

Sydney, New South Wales, Australia

Royal Brisbane & Women's Hospital

Brisbane, Queensland, Australia

Children's Hospital Queensland

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

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NCT06510699


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