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Sub-therapeutic probe drug administration to measure phenoconversion.

Rachel Conyers, MBBS (Hons)

Marliese Alexander, Doctor of Philosophy

PEGASUS aims to test acceptability and feasibility of studying phenoconversion (the change in metabolism phenotype) using probe medications in a paediatric oncology patient population. The study will be conducted in patients (6-25 years of age) with Hodgkin lymphoma or non-Hodgkin lymphoma as exemplar cohort, but with the understanding that cancer-directed and supportive care medicines of the CYP3A4, CYP2C19, and CYP2D6 metabolic pathways are commonly utilised for the treatment of many paediatric, adolescent, young adult, and adult cancers.

The study involves administration of the probe medication at timepoints which align with pre-determined hospital visits for the treatment of lymphoma and subsequent blood draws to measure the metabolism of the probe medications.

The acceptability and feasibility of this study will inform future studies in phenoconversion within the paediatric cancer population to direct more personalised precision medicine.

A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.

A Prospective Feasibility Study Investigating PhEnoconversion of CYP3A4, CYP2C19 and CYP2D6 Genotype in Paediatric and Adolescent and Young Adult patientS With an acUte diagnosiS of Hodgkin or Non-Hodgkin Lymphoma.

This measure is to help inform whether future studies of this nature are feasible and identify if any procedures need to be adjusted to ensure study participant completion.

This measure is to help inform whether future studies of this nature are feasible and identify if the method for probe drug detection requires improvement.

This measure is to help inform whether future studies of this nature are feasible and identify if the phenotype can be clearly classified at each timepoint; (i) Prior to commencing first lymphoma chemotherapy cycle (ii) 2 months (week 8) (iii) 4 months (week 16) (iv) Completion of therapy (\> week 16) (v) Up to a maximum of 2 febrile neutropenic episodes and for how many patients.

This measure is to help inform whether future studies of this nature are feasible and acceptable. Participants will complete the survey which asks 26 questions, with a numerical scale of 1-7 or a wording scale of 7 choices depending on the question.

This measure is to help inform whether future studies of this nature are feasible and identify if/how many adverse events are experienced during probe drug administration.

This measure is to help inform whether future studies of this nature are feasible and identify if genotype and phenotype mismatch occurs throughout each timepoint and the overall study.

This measure is to help inform whether future studies of this nature are feasible, to identify any variables that stand out and inform future research questions.

This measure is to identify if there are fluctuations within the inflammatory profile of the patients which helps to inform whether future studies of this nature are feasible. The panel detects a comprehensive set of studied and biologically relevant inflammatory markers including those shown to be predictive of severe infection in children with cancer and febrile neutropenia when out of normal ranges.

Murdoch Childrens Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.	NCT06383338	Hodgkin Lymphom... Non Hodgkin Lym...	Omeprazole Dextromethorpha...	6 Years - 25 Years	Murdoch Childrens Research Institute
A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.	NCT06383338	Hodgkin Lymphom... Non Hodgkin Lym...	Omeprazole Dextromethorpha...	6 Years - 25 Years	Murdoch Childrens Research Institute

Spots Global Cancer Trial Database for phenoconversion