Clinical trial · Interventional
Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy
Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic
NCT03920813CI-TRIAL-00038302unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 present study was conducted to assess the population pharmacokinetics of 6-mercaptopurine (6-MP) in Pediatric Acute Lymphoblastic Leukemia (ALL) and genetic polymorphisms
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mercaptopurine | Drug | Mercaptopurine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Antitumor drugs
- description
- Mercaptopurine administered at standard dose for children with hematological neoplasms.
- interventionNames
- Drug: Mercaptopurine
Primary outcomes (2)
- measure
- Red blood cells (RBC) concentration of 6-mercaptopurine (6-MP)
- timeFrame
- at second day after oral administration
- description
- To detect of RBC 6-MP metabolite concentrations and evaluate the association of metabolite concentrations and side effects
- measure
- Genetic polymorphisms in Chinese patients with ALL
- timeFrame
- at second day after oral administration
- description
- To detect the frequencies of genetic polymorphisms of Chinese patients receiving 6-MP for treatment of ALL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients have been diagnosed with Acute Lymphoblastic Leukemia * Childhood patients who were undergoing chemotherapy or continuous follow-up after completion of chemotherapy * Patients received the phase of maintenance therapy that included oral 6-MP (\>4 weeks) and completion of ≥ 6 months according to the CCLG (Chinese Children's Leukemia Group) protocol-ALL 2015 Exclusion Criteria: * Patients with high-risk ALL (presence of higher-risk features: MRD ≥ 1% at 46 day, or age \< 6 month and white blood cell (WBC) count ≥ 300×109/L with translocations t(9;22) (q34;q11) \[BCR-ABL\], t(4;11) (q21;q23) \[AF4/MLL\], t(1;19) (q23;p13) \[E2A-PBX1\] or other MLL-rearrangements) were removed
References
Publications (0)
Data not yet available
No reference posted for this study.