Change in how kids and young adults with Hodgkin or non-Hodgkin lymphoma process medicines
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 study will test whether giving small probe medicines can show changes in how children and young adults (ages 6–25) with Hodgkin or non-Hodgkin lymphoma metabolize drugs during their cancer treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 6 Years to 25 Years |
| Sex | All |
| Sponsor | Murdoch Childrens Research Institute Academic / other |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT06383338 on ClinicalTrials.gov |
What this trial studies
The trial gives two oral probe drugs (omeprazole and dextromethorphan) at scheduled times that align with routine hospital visits for lymphoma treatment, then takes blood samples to measure how the probes are metabolized by CYP3A4, CYP2C19, and CYP2D6 pathways. It is a Phase 1 interventional feasibility and acceptability study in patients aged 6–25 with a new diagnosis of Hodgkin or non-Hodgkin lymphoma. The protocol excludes patients with prior cancer therapy, severe organ dysfunction, allergy to the probes, or those requiring urgent treatment that precludes consent. Results will inform whether larger phenoconversion studies in pediatric oncology are practical and acceptable and help design future precision-medicine dosing trials.
Who should consider this trial
Good fit: Ideal candidates are patients aged 6–25 with a new diagnosis of Hodgkin or non-Hodgkin lymphoma who can swallow or receive probe drugs via a nasogastric tube, have not had prior oncologic treatment, and can provide informed consent.
Not a fit: Patients with CTCAE Grade IV organ dysfunction, known allergy to omeprazole or dextromethorphan, prior cancer treatment, clinical instability requiring intensive care, or who need urgent therapy before consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could help identify when and how drug metabolism changes during cancer treatment and guide more personalized dosing to reduce toxicity and improve effectiveness.
How similar studies have performed: Probe-drug phenotyping has been used in adults with some informative results, but systematic measurement of phenoconversion in pediatric oncology remains novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Melbourne, Victoria
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Rachel Conyers, MBBS (Hons) — Murdoch Childrens Research Institute
- Study coordinator: Rachel Conyers, MBBS (Hons)
- Email: rachel.conyers@mcri.edu.au
- Phone: +61393455522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.