NCT04228393

The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Wei Zhao · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.

Conditions

• Acute Lymphoblastic Leukemia, Pediatric

Interventions

Type	Name	Description
DRUG	6-mercaptopurine	6-mercaptopurine was administered orally to patients once daily.
PROCEDURE	Standard treatment	The initial dose is 50mg/m2. The dose was adjusted according to white blood cells.
PROCEDURE	Individualized treatment	The initial dose is determined according to the genotypes of patients combined with Clinical Pharmacogenetics Implementation Consortium (CPIC). The dose was adjusted according to white blood cells, genotypes and the concentrations of 6-TGN in red blood cells.

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-01-14
• Last updated: 2020-01-14

Locations

1 site across 1 country: China