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NCT Number: NCT06383338

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

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.

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non Hodgkin Lymphoma

Age range

6 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location status: Recruiting

Location contact

Marliese Alexander, Doctor of Philosophy

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 6-25 years of age.
  • New diagnosis of Hodgkin Lymphoma or Non-Hodgkin Lymphoma.
  • Able to swallow and absorb oral or nasogastric tube (NGT) administration of probe drugs.
  • Able to provide written informed consent.

Exclusion criteria

  • Failure to comply with inclusion criteria.
  • Has a known previous allergy to any of the probe medications (i.e., omeprazole or dextromethorphan).
  • Common Terminology Criteria for Adverse Events (CTCAE) Grade IV end organ dysfunction (i.e., hepatic, renal, gastrointestinal).
  • Had previous oncological treatment (not first cancer diagnosis).
  • Is a clinically unstable patient requiring intensive care admission in high-risk circumstances will not be considered eligible for consent.
  • Any patient requiring urgent initiation of anti-cancer treatment outside hours where a member of the study staff is unable to approach the parent/guardian or participant for consent prior to commencing anti-cancer therapy will be ineligible for consent.
  • Unable to provide written informed consent.

Treatment and study plan

Omeprazole

Drug

Sub-therapeutic probe drug administration to measure phenoconversion.

dextromethorphan

Drug

Sub-therapeutic probe drug administration to measure phenoconversion.

Primary outcomes

  1. Proportion of patients who consent to study and complete baseline and at least two longitudinal timepoints with successful measurement of probe drug MR (Metabolic ratio)

    Time frame: 12 months, 24 Months

    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.

Secondary outcomes

  1. Percentage of participants completing all required longitudinal blood sampling

    Time frame: Baseline through to 24 Months

    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.

  2. Proportion of participants with successful detection of probe drug overall and at each sampling timepoint

    Time frame: Baseline through to 24 Months

    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.

  3. Proportion of participants where phenotype can be classified according to MR overall at each sampling timepoint

    Time frame: Baseline through to 24 Months

    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.

  4. The level of acceptability of participation in pharmacogenomic & phenoconversion testing using the PEGASUS specific survey tool (based on the Theoretical Framework of Acceptability [TFA])

    Time frame: Baseline through to 24 Months

    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.

  5. Percentage of participants experiencing an adverse event (AE) during probe drug administration

    Time frame: Baseline through to 24 Months

    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.

  6. Incidence of genotype and phenotype mismatch, overall and across longitudinal timepoints

    Time frame: Baseline through to 24 Months

    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.

  7. Proportion of participants with disease staging and biomarkers of extent of disease

    Time frame: Baseline through to 24 Months

    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.

  8. Proportion of participants with a systemic inflammatory state

    Time frame: Baseline through to 24 Months

    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.

  9. Proportion of participants taking medications involving the CYP P450 pathway

    Time frame: Baseline through to 24 Months

    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.

  10. Participant demographic information

    Time frame: Baseline

    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.

  11. Proportion of participants with other environmental factors

    Time frame: Baseline through to 24 Months

    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.

  12. Longitudinal inflammatory profile of participants with Hodgkin or non-Hodgkin Lymphoma as measured by a panel including serum levels of procalcitonin, c-reactive protein and cytokine analysis.

    Time frame: Baseline through to 24 Months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Conyers, MBBS (Hons)

CONTACT

[email protected]

+61393455522

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Registry information

Official study title

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.

Acronym: PEGASUS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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