The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Interventions
- Registration Number
- NCT04228393
- Lead Sponsor
- Wei Zhao
- 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.
- Detailed Description
To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 82
- 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.
- 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;
- Patients with other factors that researcher considers unsuitable for inclusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard treatment regimen 6-mercaptopurine 6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015. Standard treatment regimen Standard treatment 6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015. Individualized treatment regimen Individualized treatment 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. Individualized treatment regimen 6-mercaptopurine 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.
- Primary Outcome Measures
Name Time Method leukopenia 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.
thiopurine-induced leukopenia 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.
- Secondary Outcome Measures
Name Time Method hepatotoxicity 6 weeks Hepatotoxicity was defined as aspartate aminotransferase (AST) or alanine transaminase (ALT) levels 2-fold above the upper limit without cytolysis.
6-thioguanine nucleotides (6-TGN) concentrations in erythrocytes. 3 months Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.
6-methylmercaptopurine nucleotides (6-MMPN) concentrations in erythrocytes. 3 months Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.
Trial Locations
- Locations (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, China