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

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wei Zhao
• Collaborators: Children's Hospital of Hebei Province; Institute of Hematology & Blood Diseases Hospital; Qianfoshan Hospital; Qilu Hospital of Shandong University; The Affiliated Hospital of Qingdao University
• Treatments: Mercaptopurine

Criteria

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