Clinical trial Recruiting at 4 sites Observational Ages Any age to 18

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 typeObservational
AgesAny age to 18 Years
SexAll
Enrollment250 (estimated)
SponsorIRCCS Burlo Garofolo
Academic / other
Drugs / interventionschemotherapy, methotrexate
Locations4 sites (Monza, Monza Brianza and 3 other locations)
StatusRecruiting
StartedJuly 30, 2022
Main results expectedJuly 30, 2025
Study endsDecember 31, 2026
Registry record updatedJune 14, 2024
Trial IDNCT05811845 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:

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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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.