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Hodgkin LymphomaPhase 1PEGASUSNCT06383338

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

A Phase 1 study testing Omeprazole and Dextromethorphan in people with Hodgkin Lymphoma and Non Hodgkin Lymphoma, run by Murdoch Childrens Research Institute at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

PEGASUS aims to test acceptability and feasibility of studying phenoconversion (the change in metabolism phenotype) using probe medications in a paediatric oncology patient population. Read more about this study

Who is it for?
Ages 6 to 25 years
Conditions the study is for
Hodgkin Lymphoma, Non Hodgkin Lymphoma
What is being tested?
Omeprazole and Dextromethorphan
How many people
10 participants
Where
1 siteAustralia
Study dates
22 Jul 2025to Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rachel Conyers, MBBS (Hons) contact

+61393455522

rachel.conyers@mcri.edu.au

Australia1 site, 1 recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Marliese Alexander, Doctor of Philosophy

    Recruiting

Other trials in Australia

About this study

Official 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.

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.

Being tested
Omeprazole, Dextromethorphan
Keywords
Phenoconversion
Medical subject headings
Hodgkin Disease, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmeprazoleDrug

    Sub-therapeutic probe drug administration to measure phenoconversion.

  • DextromethorphanDrug

    Sub-therapeutic probe drug administration to measure phenoconversion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    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.

    Measured: 12 months, 24 Months

Secondary outcomes (12)

  1. Percentage of participants completing all required longitudinal blood sampling

    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.

    Measured: Baseline through to 24 Months

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

    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.

    Measured: Baseline through to 24 Months

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

    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.

    Measured: Baseline through to 24 Months

  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])

    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.

    Measured: Baseline through to 24 Months

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

    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.

    Measured: Baseline through to 24 Months

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

    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.

    Measured: Baseline through to 24 Months

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

    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.

    Measured: Baseline through to 24 Months

  8. Proportion of participants with a systemic inflammatory state

    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.

    Measured: Baseline through to 24 Months

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

    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.

    Measured: Baseline through to 24 Months

  10. Participant demographic information

    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.

    Measured: Baseline

  11. Proportion of participants with other environmental factors

    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.

    Measured: Baseline through to 24 Months

  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.

    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.

    Measured: Baseline through to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study start22 Jul 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06383338
Sponsor's protocol ID
PEGASUS 2023/ETH01954
Acronym
PEGASUS
Status last verified
Aug 2026
First submitted
21 Mar 2024
Last updated
27 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Helsby N, Yong M, Burns K, Findlay M, Porter D. Cyclophosphamide bioactivation pharmacogenetics in breast cancer patients. Cancer Chemother Pharmacol. 2021 Sep;88(3):533-542. doi: 10.1007/s00280-021-04307-0. Epub 2021 Jun 10.

    PubMed 34114066

  • Burns KE, Goldthorpe MA, Porteus F, Browett P, Helsby NA. CYP2C19 genotype-phenotype discordance in patients with multiple myeloma leads to an acquired loss of drug-metabolising activity. Cancer Chemother Pharmacol. 2014 Mar;73(3):651-5. doi: 10.1007/s00280-014-2409-9. Epub 2014 Feb 12.

    PubMed 24519754

  • Kim S, Ostor AJ, Nisar MK. Interleukin-6 and cytochrome-P450, reason for concern? Rheumatol Int. 2012 Sep;32(9):2601-4. doi: 10.1007/s00296-012-2423-3. Epub 2012 Mar 27.

    PubMed 22451032

  • Rodieux F, Daali Y, Rollason V, Samer CF, Ing Lorenzini K. Practice of CYP450 genotyping and phenotyping in children in a real-life setting. Front Pharmacol. 2023 Feb 27;14:1130100. doi: 10.3389/fphar.2023.1130100. eCollection 2023.

    PubMed 36937881

  • Bosilkovska M, Samer CF, Deglon J, Rebsamen M, Staub C, Dayer P, Walder B, Desmeules JA, Daali Y. Geneva cocktail for cytochrome p450 and P-glycoprotein activity assessment using dried blood spots. Clin Pharmacol Ther. 2014 Sep;96(3):349-59. doi: 10.1038/clpt.2014.83. Epub 2014 Apr 10.

    PubMed 24722393

  • Lloret-Linares C, Rollason V, Lorenzini KI, Samer C, Daali Y, Gex-Fabry M, Aubry JM, Desmeules J, Besson M. Screening for genotypic and phenotypic variations in CYP450 activity in patients with therapeutic problems in a psychiatric setting, a retrospective study. Pharmacol Res. 2017 Apr;118:104-110. doi: 10.1016/j.phrs.2016.07.002. Epub 2016 Jul 1.

    PubMed 27378571

  • Rollason V, Lloret-Linares C, Lorenzini KI, Daali Y, Gex-Fabry M, Piguet V, Besson M, Samer C, Desmeules J. Evaluation of Phenotypic and Genotypic Variations of Drug Metabolising Enzymes and Transporters in Chronic Pain Patients Facing Adverse Drug Reactions or Non-Response to Analgesics: A Retrospective Study. J Pers Med. 2020 Oct 27;10(4):198. doi: 10.3390/jpm10040198.

    PubMed 33121061

  • Ing Lorenzini K, Desmeules J, Rollason V, Bertin S, Besson M, Daali Y, Samer CF. CYP450 Genotype-Phenotype Concordance Using the Geneva Micrococktail in a Clinical Setting. Front Pharmacol. 2021 Aug 26;12:730637. doi: 10.3389/fphar.2021.730637. eCollection 2021.

    PubMed 34512355

  • Lenoir C, Niederer A, Rollason V, Desmeules JA, Daali Y, Samer CF. Prediction of cytochromes P450 3A and 2C19 modulation by both inflammation and drug interactions using physiologically based pharmacokinetics. CPT Pharmacometrics Syst Pharmacol. 2022 Jan;11(1):30-43. doi: 10.1002/psp4.12730. Epub 2021 Nov 17.

    PubMed 34791831

  • Mandrioli R, Mercolini L, Protti M. Blood and Plasma Volumetric Absorptive Microsampling (VAMS) Coupled to LC-MS/MS for the Forensic Assessment of Cocaine Consumption. Molecules. 2020 Feb 26;25(5):1046. doi: 10.3390/molecules25051046.

    PubMed 32110941

  • Doerflinger M, Haeusler GM, Li-Wai-Suen CSN, Clark JE, Slavin M, Babl FE, Allaway Z, Mechinaud F, Smyth GK, De Abreu Lourenco R, Phillips B, Pellegrini M, Thursky KA. Procalcitonin and Interleukin-10 May Assist in Early Prediction of Bacteraemia in Children With Cancer and Febrile Neutropenia. Front Immunol. 2021 May 20;12:641879. doi: 10.3389/fimmu.2021.641879. eCollection 2021.

    PubMed 34093531

  • Conyers R, Stenta T, Somogyi AA, Kirkpatrick C, Halman A, Wang S, Moore C, Khatri D, Williams E, Dyas R, Spelman T, Elliott DA, Gwee A, Alexander M. Phenoconversion of CYP3A4, CYP2C19 and CYP2D6 in Pediatrics, Adolescents and Young Adults With Lymphoma: Rationale and Design of the PEGASUS Study. Clin Transl Sci. 2025 Apr;18(4):e70209. doi: 10.1111/cts.70209.

    PubMed 40259519

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Omeprazole and Dextromethorphan in people with Hodgkin Lymphoma and Non Hodgkin Lymphoma, run by Murdoch Childrens Research Institute at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachel Conyers, MBBS (Hons) (+61393455522, rachel.conyers@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06383338, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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