NUDT15/TPMT Multi-gene Guided 6-MP Dosing in Childhood ALL Maintenance Therapy

This is a prospective, single-center clinical study to evaluate the safety and efficacy of a personalized 6-mercaptopurine (6-MP) dosing strategy guided by NUDT15 and TPMT genotypes in children with Acute Lymphoblastic Leukemia (ALL) during maintenance therapy. The study compares this gene-guided strategy with historical controls to assess if it reduces the incidence of Grade ≥3 neutropenia and infection events.

NCT Number	NCT07462299
Lead Sponsor	The Children's Hospital of Zhejiang University School of Medicine Collaborators: Zhejiang University
Conditions	Childhood Acute Lymphoblastic Leukemia
Enrollment	110 participants
Start Date	2026-02-20
Primary Completion	2028-01-01 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-10