Optimizing mercaptopurine treatment for children with leukemia
Optimizing the Maintenance Phase of Childhood Acute Lymphoblastic Leukemia AIEOP Protocol Through Mercaptopurine Therapeutic Drug Monitoring and Proactive Strategies for Adherence
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 |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 4 sites (Monza, Monza Brianza and 3 other locations) |
| Trial ID | NCT05811845 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old who have been newly diagnosed with acute lymphoblastic leukemia.
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.
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 performed: Other studies have shown promise in optimizing leukemia treatment through therapeutic drug monitoring, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed ALL * Age \<18 years at diagnosis * Written informed consent given Exclusion Criteria: \-
Where this trial is running
Monza, Monza Brianza and 3 other locations
- 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
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.