Clinical trial · Observational
The Influence of Thiopurine Methyltransferase Activity on Toxicity After High-dose Methotrexate in Childhood Acute Lymphoblastic Leukemia
The Influence of Thiopurine Methyltransferase Activity on Bone Marrow- and Hepato-toxicity After High-dose Methotrexate 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)
The purpose of this study is to explore the impact of thiopurine methyltransferase (TPMT) activity on the risk of HDM-related bone marrow- and hepatotoxicity and treatment interruptions during maintenance therapy for children with ALL. Hypothesis of the study: Patients with TPMT activity compatible with TPMT low activity polymorphisms have an increased risk of toxicity following high-dose methotrexate (HDM) compared to children with normal TPMT activity.
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Toxicity of treatment, degree of myelo- and hepatotoxicity
- timeFrame
- 7-28 days after high-dose methotrexate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * included in the NOPHO ALL92 protocol * available TPMT phenotype * treated at least once with HD-MTX 5.0 g/m2 (+- 10%) during maintenance therapy * at least one available measurement on blood counts or alanine aminotransferase levels 28 days after HD-MTX Exclusion Criteria: * HR ALL * children with Down Syndrome * Events during maintenance therapy * TPMT deficiency
References
Publications (0)
Data not yet available