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Trial Title:
A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.
NCT ID:
NCT06383338
Condition:
Hodgkin Lymphoma
Non Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Levomethorphan
Dextromethorphan
Omeprazole
Conditions: Keywords:
Phenoconversion
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Omeprazole
Description:
Sub-therapeutic probe drug administration to measure phenoconversion.
Intervention type:
Drug
Intervention name:
Dextromethorphan
Description:
Sub-therapeutic probe drug administration to measure phenoconversion.
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.
Criteria for 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.
Gender:
All
Minimum age:
6 Years
Maximum age:
25 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Contact:
Last name:
Marliese Alexander, Doctor of Philosophy
Start date:
March 2025
Completion date:
March 2026
Lead sponsor:
Agency:
Murdoch Childrens Research Institute
Agency class:
Other
Source:
Murdoch Childrens Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06383338
