Pediatric Acute Lymphoblastic Leukemia
Conditions
Interventions
Experimental Group:Individualized 6-MP dose adjustment guided by multi-gene testing
Sponsors
Children's Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age 1 - 18 years old, diagnosed with ALL and scheduled to enter the maintenance treatment stage. 2. Plan to receive oral 6-MP as part of the maintenance chemotherapy. 3. NUDT15 and TPMT gene tests have been completed and the results are available. 4. Baseline liver and kidney functions meet the tolerance criteria (e.g., ALT/AST <= 2.5 times ULN). 5. Guardian has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Down syndrome ALL or other genetic syndromes requiring specialized treatment protocols . 2.Documented relapse or refractory disease before the start of the maintenance phase. 3.Prior history of hematopoietic stem cell transplantation. 4.Severe liver impairment, renal dysfunction, or active infections preventing entry into the maintenance phase .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of >=grade 3 neutropenia during maintenance therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative Dose Intensity (RDI) of 6-Mercaptopurine (6-MP);Incidence of Severe Infection and Febrile Neutropenia (FN);Minimal Residual Disease (MRD) Negative Rate;Percentage of Days with 6-MP Treatment Interruption or Dose Reduction; | — |
Countries
China
Contacts
Public ContactXia Tian
Children's Hospital,Zhejiang University School of Medicine
Outcome results
None listed