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

Phase 2/3 Unknown 82 enrolled Wei Zhao Children's Hospital of Hebei Province · collab Institute of Hematology & Blood Diseases Hospital, China · collab Qianfoshan Hospital · collab Qilu Hospital of Shandong University · collab The Affiliated Hospital of Qingdao University · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2020-02-01
Primary completion: 2022-12-31
Completion: 2022-12-31

Publications

Zhou 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MERCAPTOPURINE ANHYDROUS	Small molecule	10 mg/m2	Oral
Subject	MERCAPTOPURINE ANHYDROUS	Small molecule	50 mg/m2	Oral

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

Summary

Timeline

Publications

Drugs

Indications