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

September 1, 2025 updated by: Murdoch Childrens Research Institute

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
          • Marliese Alexander, Doctor of Philosophy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months, 24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline through to 24 Months
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.
Baseline through to 24 Months
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.
Baseline through to 24 Months
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.
Baseline through to 24 Months
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.
Baseline through to 24 Months
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.
Baseline through to 24 Months
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.
Baseline through to 24 Months
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.
Baseline through to 24 Months
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.
Baseline through to 24 Months
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.
Baseline
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.
Baseline through to 24 Months
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.
Baseline through to 24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Murdoch Childrens Research Institute

Investigators

  • Principal Investigator: Rachel Conyers, MBBS (Hons), Murdoch Childrens Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

April 20, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEGASUS 2023/ETH01954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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