Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy
- Registration Number
- NCT03920813
- Lead Sponsor
- Shandong University
- Brief Summary
The present study was conducted to assess the population pharmacokinetics of 6-mercaptopurine (6-MP) in Pediatric Acute Lymphoblastic Leukemia (ALL) and genetic polymorphisms
- Detailed Description
The investigators' purpose was to identify genetic factors and metabolite concentrations associated with both hematological toxicity in patients with ALL maintained on 6-MP in Chinese.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- Patients have been diagnosed with Acute Lymphoblastic Leukemia
- Childhood patients who were undergoing chemotherapy or continuous follow-up after completion of chemotherapy
- Patients received the phase of maintenance therapy that included oral 6-MP (>4 weeks) and completion of ≥ 6 months according to the CCLG (Chinese Children's Leukemia Group) protocol-ALL 2015
Exclusion Criteria
- Patients with high-risk ALL (presence of higher-risk features: MRD ≥ 1% at 46 day, or age < 6 month and white blood cell (WBC) count ≥ 300×109/L with translocations t(9;22) (q34;q11) [BCR-ABL], t(4;11) (q21;q23) [AF4/MLL], t(1;19) (q23;p13) [E2A-PBX1] or other MLL-rearrangements) were removed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Antitumor drugs Mercaptopurine Mercaptopurine administered at standard dose for children with hematological neoplasms.
- Primary Outcome Measures
Name Time Method Genetic polymorphisms in Chinese patients with ALL at second day after oral administration To detect the frequencies of genetic polymorphisms of Chinese patients receiving 6-MP for treatment of ALL
Red blood cells (RBC) concentration of 6-mercaptopurine (6-MP) at second day after oral administration To detect of RBC 6-MP metabolite concentrations and evaluate the association of metabolite concentrations and side effects
- Secondary Outcome Measures
Name Time Method