CCCG-ALL2025 LR-B-ALL plan is designed based on the CCCG-ALL2020 plan. This is a clinical trial using 14 days of blinatumomab (Blina-14) as early intensification after induction therapy and 2nd Blina-14 in consolidation therapy in all newly diagnosed provisional low-risk (LR) pediatric acute lymphoblastic leukemia (ALL) patients, regardless of measurable residual diseases (MRD) status. We will compare the efficacy of chemotherapy combined with Blina-14, comparing to CAT+ intensification or historical regimens. Patients with early remission in depth will receive chemo-light late intensification and maintenance therapy afterwards. Early complete remission in depth and maintenance reduction will be determined by next-generation sequencing (Ig-NGS MRD).
Conditions: Acute Lymphoblastic Leukemia ALL, Childhood Leukemia, Acute Lymphoblastic, B Cell Acute Lymphoblastic Leukemia (B-ALL)
Eligibility Criteria
Inclusion Criteria
- Must meet all items below:
- Age older than 1 year and younger than 18 years.
- Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
- Diagnosis of B-ALL by immunophenotyping.
- Low risk group
Exclusion Criteria
- Should be excluded in the presence of any item below:
- T-ALL
- I/HR B-ALL group
- sIgM+
- Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
- Philadelphia chromosome positive ALL (Ph-ALL)
- ALL evolved from chronic myeloid leukemia (CML).
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction
- Secondary leukemia
- Known underlying congenital immunodeficiency or metabolic disease
- Congenital heart disease with cardiac insufficiency.
- Glucocorticoid treatment for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)
Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.