Clinical trial · Interventional
The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China
NCT04228393CI-TRIAL-00042783unknownPhase 2 / Phase 3ClinicalTrials.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 purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. The individualized administration of 6-MP was established in Chinese children with acute lymphoblastic leukemia.
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, Pediatric | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6-mercaptopurine | Drug | Mercaptopurine | ALIAS |
| Individualized treatment | Procedure | — | UNRESOLVED |
| Standard treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard treatment regimen
- description
- 6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015.
- interventionNames
- Drug: 6-mercaptopurine
- Procedure: Standard treatment
- type
- EXPERIMENTAL
- label
- Individualized treatment regimen
- description
- 6-mercaptopurine was administered on the basis of Chinese Children Cancer Group (CCCG) protocol-ALL 2015 combined with Clinical Pharmacogenetics Implementation Consortium (CPIC), genotypes and the concentrations of 6-TGN in red blood cells.
- interventionNames
- Drug: 6-mercaptopurine
- Procedure: Individualized treatment
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed diagnosis of acute lymphoblastic leukemia; 2. Age 1-18y at time of initial diagnosis; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 4. Informed consent signed by the patients parents or guardians before initiation of the study. Exclusion Criteria: 1. Ph-positive ALL, matrue B-cell ALL, BC-CML; 2. Secondary to immunodeficiency, second cancer； 3. Abnormal liver and kidney function; 4. Patients divided into intermediate or high risk groups according to the risk grouping criteria of the Chinese Children Cancer Group (CCCG) protocol-ALL 2015; 5. Patients who enrolled in another clinical trial; 6. Expected survival time less than the treatment cycle; 7. Patients with other factors that researcher considers unsuitable for inclusion
References
Publications (1)
- DERIVEDZhou Y, Wang L, Sun LR, Zhang L, Wang HM, Liu XT, Yang F, Wu KL, Liang YL, Zhao BB, Zhuang Y, Fu JQ, Song C, Li Y, Wang LZ, Xu HJ, Gu Y, van den Anker J, Ju XL, Zhu XF, Zhao W. Individualized Use of 6-Mercaptopurine in Chinese Children with ALL: A Multicenter Randomized Controlled Trial. Clin Pharmacol Ther. 2024 Feb;115(2):213-220. doi: 10.1002/cpt.3061. Epub 2023 Oct 16. PMID 37753808