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

Wei Zhao

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Treatments: Drug: 6-mercaptopurine; Procedure: Individualized treatment; Procedure: Standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04228393

2020-6-mercaptopurine-001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 82 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Standard treatment regimen

Active Comparator group

Description:

6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015.

Treatment:

Procedure: Standard treatment

Drug: 6-mercaptopurine

Individualized treatment regimen

Experimental group

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.

Treatment:

Procedure: Individualized treatment

Drug: 6-mercaptopurine