NUDT15/TPMT Multi-gene Guided 6-MP Dosing in Childhood ALL Maintenance Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NUDT15/TPMT genotype-guided 6-MP dosing.
- Who it may be relevant to
- Registry conditions: Childhood Acute Lymphoblastic Leukemia. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study of NUDT15/TPMT Multi-gene Combined Guidance on 6-MP Dosage During Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia
Overview
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.
Interventions
- Drug NUDT15/TPMT genotype-guided 6-MP dosing
Initial 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.
Primary outcome measures
- Cumulative Incidence of Grade 3 or Higher Neutropenia [Time frame: From the start of maintenance therapy up to Month 12]
Secondary outcome measures (2)
- Incidence of Severe Infection and Febrile Neutropenia (FN) [Time frame: Up to 12 months from the start of maintenance therapy]
- Relative Dose Intensity (RDI) of 6-Mercaptopurine (6-MP) [Time frame: Up to 12 months from the start of maintenance therapy]
Eligibility criteria
Inclusion criteria
Diagnosed with ALL and scheduled for maintenance therapy. Plan to receive oral 6-MP. NUDT15 and TPMT genotyping results available. Baseline liver and kidney function within acceptable limits (ALT/AST ≤ 2.5xULN, etc.).
Signed informed consent. -
Exclusion criteria
Down syndrome. Relapsed/refractory disease before maintenance. Prior hematopoietic stem cell transplantation. Severe organ dysfunction or uncontrolled infection.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Children's Hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07462299 · 2026-IRB-0015-P-01