drugset / Trial / NCT07462299
NUDT15/TPMT Multi-gene Guided 6-MP Dosing in Childhood ALL Maintenance Therapy
Not yet recruiting
110 enrolled
The Children's Hospital of Zhejiang University School of Medicine
Zhejiang University · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 50 mg/m2 | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 75 mg/m2 | — |