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

January 10, 2020 updated by: Wei Zhao
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tanjin, Tianjin, China, 300020
        • State Key Laboratory of Experimental Haematology, Department of Paediatric Haematology, Institute of Haematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard treatment regimen
6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015.
Drug: 6-mercaptopurine
6-mercaptopurine was administered orally to patients once daily.
Other Names:
  • 6-MP
Procedure: Standard treatment
The initial dose is 50mg/m2. The dose was adjusted according to white blood cells.
Experimental: Individualized treatment regimen
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.
Drug: 6-mercaptopurine
6-mercaptopurine was administered orally to patients once daily.
Other Names:
  • 6-MP
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
leukopenia
Time Frame: 6 weeks
Leukopenia was graded by common toxicity criteria as follows: Grade 3, 1.0-2.0 × 109/L, and Grade 4, < 1.0 × 109/L.
6 weeks
thiopurine-induced leukopenia
Time Frame: 6-weeks
Resolution of leukopenia was determined after 6-MP dose reduction or discontinuation, both in the absence of other apparent causes for the leukopenia or its disappearance.
6-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hepatotoxicity
Time Frame: 6 weeks
Hepatotoxicity was defined as aspartate aminotransferase (AST) or alanine transaminase (ALT) levels 2-fold above the upper limit without cytolysis.
6 weeks
6-thioguanine nucleotides (6-TGN) concentrations in erythrocytes.
Time Frame: 3 months
Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.
3 months
6-methylmercaptopurine nucleotides (6-MMPN) concentrations in erythrocytes.
Time Frame: 3 months
Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei Zhao

Collaborators

Qilu Hospital of Shandong University
The Affiliated Hospital of Qingdao University
Institute of Hematology & Blood Diseases Hospital
Qianfoshan Hospital
Children's Hospital of Hebei Province

Investigators

  • Principal Investigator: Wei Zhao, Ph.D, Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-6-mercaptopurine-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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