NCT06383338 A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.
| NCT ID | NCT06383338 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Murdoch Childrens Research Institute |
| Condition | Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-07-22 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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.
Contact & Investigator
Rachel Conyers, MBBS (Hons)
PRINCIPAL INVESTIGATOR
Murdoch Childrens Research Institute
Frequently Asked Questions
Who can join the NCT06383338 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 25 Years, studying Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06383338 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06383338 currently recruiting?
Yes, NCT06383338 is actively recruiting participants. Contact the research team at rachel.conyers@mcri.edu.au for enrollment information.
Where is the NCT06383338 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT06383338 clinical trial?
NCT06383338 is sponsored by Murdoch Childrens Research Institute. The principal investigator is Rachel Conyers, MBBS (Hons) at Murdoch Childrens Research Institute. The trial plans to enroll 10 participants.