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

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

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.

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

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