Minimising Adverse Drug Reactions and Verifying Economic Legitimacy in Children (MARVEL-PIC)

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Dec 19, 2022

Keywords

ClinConnect Summary

The MARVEL-PIC trial is a study aimed at improving the care of children with cancer, particularly those who are undergoing treatment like bone marrow transplants. The main goal is to see if a personalized approach to prescribing medications can help reduce side effects from these drugs and improve the patients' quality of life. In this trial, children under 18 with a new cancer diagnosis or those receiving a specific type of transplant will be randomly assigned to either receive personalized medication guidance or standard treatment for 12 weeks. Researchers will follow up with participants for up to a year to gather information about their symptoms and overall well-being through surveys.

To be eligible for this trial, children must be under 18 years old and have a recent cancer diagnosis or be receiving a hematopoietic stem cell transplant. They should be starting a new medication that has specific guidelines available, and both the child and their parent must agree to participate. Participants can expect to receive either personalized support or standard care, and their experiences will be tracked over time to see which approach works better. It's important to note that certain conditions, like severe liver or kidney issues, may exclude some patients from participating in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \< 18 years
• • New cancer diagnosis or patient receiving HSCT.
• • Must receive a first prescription for one or more of the drugs for which the CPIC guideline is available, which is prescribed to them in routine care.
• • Parent or patient is able and willing to give consent for patient to take part and be followed up for at least 12 weeks.
• • Patient is amenable to venepuncture and blood draw (5mL \< 40 kgs, 12 mL \> 40kgs)
• • Patient and/or parent is able and willing to sign an informed consent form.
• • Patient and/or parent is able to complete Ped-PRO-CTCAE survey in English, Italian or Chinese.
• • Study enrolment limit has not been reached.
• Exclusion Criteria:
• • Age \> 18 years.
• • Patient has a life expectancy estimated to be less than three months by the treating clinical team.
• • Duration of the drug of inclusion total treatment length is planned to be less than one week.
• • Patient and/or parent is unable to consent to the study.
• • Patient and/or parent is unwilling to take part in the study.
• • Patient and/or parent is able unable to complete Ped-PRO-CTCAE survey in English, Italian or Chinese.
• • Patient has existing impaired hepatic or renal function for which a lower dose or alternate drug selection are already part of current routine care.
• • Patient has a glomerular filtration rate of less than 15 mL/min per 1.73m2.
• • Patient has advanced liver failure.