Optimizing mercaptopurine treatment for children with leukemia
Official title: Optimizing the Maintenance Phase of Childhood Acute Lymphoblastic Leukemia AIEOP Protocol Through Mercaptopurine Therapeutic Drug Monitoring and Proactive Strategies for Adherence
Run by IRCCS Burlo Garofolo · NCT05811845 · Data updated 2026-11-12
This study is trying to find the best way to use mercaptopurine to help children with leukemia stay healthy and avoid side effects during their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 4 sites (Monza, Monza Brianza and 3 other locations) |
| Status | Recruiting |
| Started | July 30, 2022 |
| Main results expected | July 30, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | June 14, 2024 |
| Trial ID | NCT05811845 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children under 18 years old who have been newly diagnosed with acute lymphoblastic leukemia.
✕Probably not a fit
Patients who are older than 18 years or those who have not been newly diagnosed with ALL may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on children diagnosed with acute lymphoblastic leukemia (ALL) and aims to optimize the maintenance phase of treatment using mercaptopurine (MP). The study will monitor the therapeutic drug levels of MP to ensure effective dosing and minimize potential toxicities associated with the medication. By analyzing individual responses to MP, the research seeks to improve event-free survival rates in pediatric patients undergoing treatment for ALL. The study involves collaboration with several pediatric hospitals in Italy to gather comprehensive data on treatment outcomes.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced side effects for children with ALL.
How similar studies have gone: Other studies have shown promise in optimizing leukemia treatment through therapeutic drug monitoring, suggesting that this approach may be beneficial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed ALL * Age \<18 years at diagnosis * Written informed consent given Exclusion Criteria: \-
Where it's running
-
Fondazione MBBM / A.O. San Gerardo
Monza, Monza Brianza, Italy Recruiting -
IRCCS Ospedale Pediatrico "Bambino Gesù"
Roma, Italy Recruiting -
Presidio Infantile Regina Margherita
Torino, Italy Recruiting -
IRCCS materno infantile Burlo Garofolo
Trieste, Italy Recruiting
Study contacts
- Study coordinator: Marco Rabusin, MD
- Email: marco.rabusin@burlo.trieste.it
- Phone: +390403785111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.