drugset / Trial / NCT07462299

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

NCT07462299

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-02-20
Primary completion
2028-01-01
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject MERCAPTOPURINE ANHYDROUS Small molecule 50 mg/m2
Subject MERCAPTOPURINE ANHYDROUS Small molecule 75 mg/m2