A Phase 2/3 interventional study of 6-mercaptopurine and Standard treatment in Acute Lymphoblastic Leukemia, Pediatric, sponsored by Wei Zhao. Status unknown at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2020-01-14.
Sponsored by Wei Zhao · Phase 2/3, Interventional, and Treatment
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.
To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 82 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Exclusion Criteria:
6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015.
Drug: 6-mercaptopurine · Procedure: Standard 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.
Drug: 6-mercaptopurine · Procedure: Individualized treatment
6-mercaptopurine was administered orally to patients once daily.
Also known as: 6-MP
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.
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.
Time frame: 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.
Time frame: 6-weeks
hepatotoxicity
Hepatotoxicity was defined as aspartate aminotransferase (AST) or alanine transaminase (ALT) levels 2-fold above the upper limit without cytolysis.
Time frame: 6 weeks
6-thioguanine nucleotides (6-TGN) concentrations in erythrocytes.
Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.
Time frame: 3 months
6-methylmercaptopurine nucleotides (6-MMPN) concentrations in erythrocytes.
Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.
Time frame: 3 months
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Wei Zhao