Recruiting NCT07152041

Newly-diagnosed Pediatric Ph-positive B-ALL Protocol

LeukemiaPhase 3CD19

This prospective clinical trial evaluates the effectiveness and safety of "chemotherapy-light" regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3/CD19 T cell engager blinatumomab, and the BCL-2 selective inhibitor venetoclax for newly diagnosed pediatric/adolescent patients with Ph+ ALL. The CCCG-Ph+ B-ALL-2025 protocol will be modified as following compared to the CCCG-ALL-2020 protocol

Conditions: Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+), Childhood Leukemia, Acute Lymphoblastic

Eligibility Criteria

Inclusion Criteria

  • Must meet all items below:
  • Age older than 1 month to younger 18 years.
  • Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.
  • Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.

Exclusion Criteria

  • Should be excluded if had any item below:
  • ALL evolved from CML.
  • Known underlying congenital immunodeficiency or metabolic disease.
  • Congenital heart disease with cardiac insufficiency.
  • Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug.
  • Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases.
  • Subjects with significant CNS disorder (e.g., uncontrolled seizure disorder, autoimmune disease involving CNS).
  • Treated with glucocorticoids for ≥14 days, or targeted inhibitor for \> 7 days within one month before enrollment, or any chemotherapy or any systemic anticancer therapy (including but not limited to any TKI) 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.