Clinical trial · Interventional
NUDT15/TPMT Multi-gene Guided 6-MP Dosing in Childhood ALL Maintenance Therapy
A Prospective Study of NUDT15/TPMT Multi-gene Combined Guidance on 6-MP Dosage During Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NUDT15/TPMT genotype-guided 6-MP dosing | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Genotype-guided Dosing Group
- description
- All participants will receive 6-MP maintenance therapy with dosage adjustments based on their NUDT15 and TPMT genotype status.
- interventionNames
- Drug: NUDT15/TPMT genotype-guided 6-MP dosing
Primary outcomes (1)
- measure
- Cumulative Incidence of Grade 3 or Higher Neutropenia
- timeFrame
- From the start of maintenance therapy up to Month 12
- description
- 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.
Secondary outcomes (2)
- measure
- Incidence of Severe Infection and Febrile Neutropenia (FN)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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. \-
References
Publications (0)
Data not yet available