Not Yet RecruitingNot Applicable

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

China110 participantsStarted 2026-02-20

Plain-language 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.

Who can participate

Age range1 Year – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. \-

What they're measuring

Cumulative Incidence of Grade 3 or Higher Neutropenia

Timeframe: From the start of maintenance therapy up to Month 12

Trial details

NCT IDNCT07462299

SponsorThe Children's Hospital of Zhejiang University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-01

Contact for this trial

tian xia, MD

+86 15267035696 xiatiansky2013@163.com

View on ClinicalTrials.gov More Childhood Acute Lymphoblastic Leukemia trials