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.
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Single group
NUDT15/TPMT genotype-guided 6-MP dosing
DrugInitial dosage of 6-Mercaptopurine (6-MP) is stratified based on NUDT15 and TPMT genotypes: Normal metabolizers: 100% standard dose (50-75 mg/m\^2/d). Intermediate metabolizers: 30-80% of the recommended dose. Poor metabolizers: 10-30% of the recommended dose. Subsequent dosage adjustments are made based on toxicity monitoring and therapeutic drug monitoring (TDM) of 6-TGN and 6-MMP levels.
Cumulative Incidence of Grade 3 or Higher Neutropenia
Defined according to NCI CTCAE v5.0 criteria. Grade ≥3 neutropenia is defined as an Absolute Neutrophil Count (ANC) \< 1000/mm³. The measure reports the percentage of participants who experience at least one episode of Grade ≥3 neutropenia.
Incidence of Severe Infection and Febrile Neutropenia (FN)
The percentage of participants experiencing Grade 3 or higher infections (assessed per NCI CTCAE v5.0) or FN events. FN is defined as a single oral temperature ≥38.3°C or ≥38.0°C sustained for more than 1 hour, combined with an ANC \< 500/mm³.
Relative Dose Intensity (RDI) of 6-Mercaptopurine (6-MP)
RDI is calculated as the ratio of the actual cumulative dose of 6-MP received by the participant to the recommended cumulative dose based on the standard protocol (calculated by body surface area). The result is reported as a percentage.
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The Children's Hospital of Zhejiang University School of Medicine
Lead sponsor
Zhejiang University
Collaborator
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