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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06383338




Registration number
NCT06383338
Ethics application status
Date submitted
21/03/2024
Date registered
25/04/2024

Titles & IDs
Public title
A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.
Scientific 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.
Secondary ID [1] 0 0
PEGASUS 2023/ETH01954
Universal Trial Number (UTN)
Trial acronym
PEGASUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma 0 0
Non Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Omeprazole
Treatment: Drugs - Dextromethorphan

Treatment: Drugs: Omeprazole
Sub-therapeutic probe drug administration to measure phenoconversion.

Treatment: Drugs: Dextromethorphan
Sub-therapeutic probe drug administration to measure phenoconversion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
12 months, 24 Months
Secondary outcome [1] 0 0
Percentage of participants completing all required longitudinal blood sampling
Timepoint [1] 0 0
Baseline through to 24 Months
Secondary outcome [2] 0 0
Proportion of participants with successful detection of probe drug overall and at each sampling timepoint
Timepoint [2] 0 0
Baseline through to 24 Months
Secondary outcome [3] 0 0
Proportion of participants where phenotype can be classified according to MR overall at each sampling timepoint
Timepoint [3] 0 0
Baseline through to 24 Months
Secondary outcome [4] 0 0
The level of acceptability of participation in pharmacogenomic & phenoconversion testing using the PEGASUS specific survey tool (based on the Theoretical Framework of Acceptability [TFA])
Timepoint [4] 0 0
Baseline through to 24 Months
Secondary outcome [5] 0 0
Percentage of participants experiencing an adverse event (AE) during probe drug administration
Timepoint [5] 0 0
Baseline through to 24 Months
Secondary outcome [6] 0 0
Incidence of genotype and phenotype mismatch, overall and across longitudinal timepoints
Timepoint [6] 0 0
Baseline through to 24 Months
Secondary outcome [7] 0 0
Proportion of participants with disease staging and biomarkers of extent of disease
Timepoint [7] 0 0
Baseline through to 24 Months
Secondary outcome [8] 0 0
Proportion of participants with a systemic inflammatory state
Timepoint [8] 0 0
Baseline through to 24 Months
Secondary outcome [9] 0 0
Proportion of participants taking medications involving the CYP P450 pathway
Timepoint [9] 0 0
Baseline through to 24 Months
Secondary outcome [10] 0 0
Participant demographic information
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
Proportion of participants with other environmental factors
Timepoint [11] 0 0
Baseline through to 24 Months
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Baseline through to 24 Months

Eligibility
Key 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.
Minimum age
6 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rachel Conyers, MBBS (Hons)
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rachel Conyers, MBBS (Hons)
Address 0 0
Country 0 0
Phone 0 0
+61393455522
Fax 0 0
Email 0 0
rachel.conyers@mcri.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06383338