NCT07462299

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
30mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Feb 2026Dec 2028

Study Start

First participant enrolled

February 20, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

March 2, 2026

Last Update Submit

March 5, 2026

Conditions

Childhood Acute Lymphoblastic Leukemia

Keywords

NUDT15TPMT6-MPPharmacogeneticsMaintenance Therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    From the start of maintenance therapy up to Month 12

Secondary Outcomes (2)

  • Incidence of Severe Infection and Febrile Neutropenia (FN)

    Up to 12 months from the start of maintenance therapy

  • Relative Dose Intensity (RDI) of 6-Mercaptopurine (6-MP)

    Up to 12 months from the start of maintenance therapy

Study Arms (1)

Genotype-guided Dosing Group

EXPERIMENTAL

All participants will receive 6-MP maintenance therapy with dosage adjustments based on their NUDT15 and TPMT genotype status.

Drug: NUDT15/TPMT genotype-guided 6-MP dosing

Interventions

NUDT15/TPMT genotype-guided 6-MP dosingDRUG

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.

Genotype-guided Dosing Group

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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. -

You may not qualify if:

  • Down syndrome. Relapsed/refractory disease before maintenance. Prior hematopoietic stem cell transplantation. Severe organ dysfunction or uncontrolled infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Tian Xia, MD

    Children's Hospital, Zhejiang University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

tian xia, MD

CONTACT

+86 15267035696xiatiansky2013@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 10, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

CN(1)