The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China
1 other identifier
interventional
82
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2020
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 14, 2020
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJanuary 14, 2020
January 1, 2020
2.9 years
January 9, 2020
January 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
leukopenia
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
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 Outcomes (3)
hepatotoxicity
6 weeks
6-thioguanine nucleotides (6-TGN) concentrations in erythrocytes.
3 months
6-methylmercaptopurine nucleotides (6-MMPN) concentrations in erythrocytes.
3 months
Study Arms (2)
Standard treatment regimen
ACTIVE COMPARATOR6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015.
Individualized treatment regimen
EXPERIMENTAL6-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.
Interventions
6-mercaptopurine was administered orally to patients once daily.
The initial dose is 50mg/m2. The dose was adjusted according to white blood cells.
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.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of acute lymphoblastic leukemia;
- Age 1-18y at time of initial diagnosis;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Informed consent signed by the patients parents or guardians before initiation of the study.
You may not qualify if:
- Ph-positive ALL, matrue B-cell ALL, BC-CML;
- Secondary to immunodeficiency, second cancer；
- Abnormal liver and kidney function;
- Patients divided into intermediate or high risk groups according to the risk grouping criteria of the Chinese Children Cancer Group (CCCG) protocol-ALL 2015;
- Patients who enrolled in another clinical trial;
- Expected survival time less than the treatment cycle;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wei Zhaolead
- Institute of Hematology & Blood Diseases Hospital, Chinacollaborator
- Qianfoshan Hospitalcollaborator
- Qilu Hospital of Shandong Universitycollaborator
- Children's Hospital of Hebei Provincecollaborator
- The Affiliated Hospital of Qingdao Universitycollaborator
Study Sites (1)
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
Tanjin, Tianjin Municipality, 300020, China
Related Publications (1)
Zhou Y, Wang L, Sun LR, Zhang L, Wang HM, Liu XT, Yang F, Wu KL, Liang YL, Zhao BB, Zhuang Y, Fu JQ, Song C, Li Y, Wang LZ, Xu HJ, Gu Y, van den Anker J, Ju XL, Zhu XF, Zhao W. Individualized Use of 6-Mercaptopurine in Chinese Children with ALL: A Multicenter Randomized Controlled Trial. Clin Pharmacol Ther. 2024 Feb;115(2):213-220. doi: 10.1002/cpt.3061. Epub 2023 Oct 16.
PMID: 37753808DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Zhao, Ph.D
Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor; Head of department of clinical pharmacy and pharmacology
Study Record Dates
First Submitted
January 9, 2020
First Posted
January 14, 2020
Study Start
February 1, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
January 14, 2020
Record last verified: 2020-01