Acute Lymphoblastic Leukemia
Conditions
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.
Interventions
DRUGMercaptopurine
Dose of mercaptopurine was adjusted to maintain a target white blood cells (WBC) between 2.0-3.0 × 109/L.
Sponsors
Shandong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Outcome results
None listed