MedTrace Logo

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

NCT04228393 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2020-01-14

No results posted yet for this study

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.

Conditions

  • Acute Lymphoblastic Leukemia, Pediatric

Interventions

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.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    collaborator OTHER

  • Qianfoshan Hospital

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Children's Hospital of Hebei Province

    collaborator OTHER

  • The Affiliated Hospital of Qingdao University

    collaborator OTHER

  • Wei Zhao

    lead OTHER

Principal Investigators

  • Wei Zhao, Ph.D · Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04228393 on ClinicalTrials.gov