Treatment plan for newly diagnosed pediatric Philadelphia chromosome–positive B‑cell acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This protocol replaces dasatinib with the third‑generation TKI olverembatinib and pairs it with a short vincristine/prednisone lead‑in followed by a 28‑day blinatumomab induction. Consolidation includes high‑dose methotrexate with blinatumomab cycles and reduced‑dose cytarabine, while cyclophosphamide and asparaginase are omitted to reduce toxicity. Early maintenance alternates dexamethasone/vincristine plus either venetoclax or daunorubicin for five cycles after MTX and 6‑MP, and the plan includes serial MRD monitoring by IgH NGS and parallel CSF/peripheral blood olverembatinib level checks. The multicenter Phase 3 protocol enrolls children and adolescents (older than 1 month to under 18 years) at participating hospitals in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Must meet all items below:

1. Age older than 1 month to younger 18 years.
2. Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.
3. 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:

1. ALL evolved from CML.
2. Known underlying congenital immunodeficiency or metabolic disease.
3. Congenital heart disease with cardiac insufficiency.
4. Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug.
5. Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases.
6. Subjects with significant CNS disorder (e.g., uncontrolled seizure disorder, autoimmune disease involving CNS).
7. 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).
8. Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria.

Where it's running

• Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
  Tianjin, Tianjin Municipality, China Recruiting
• Anhui Medical University Second Affiliated Hospita
  Hefei, Anhui, China Not yet recruiting
• Chongqing Medical University Affiliated Children's Hospital
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Not yet recruiting
• Guangzhou Women and Children's Medical Center
  Guangzhou, Guangdong, China Not yet recruiting
• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

• Principal investigator: Xiaofan Zhu, MD — Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
• Study coordinator: Jingliao Zhang, MD
• Email: zhangjingliao@ihcams.ac.cn
• Phone: +86 22 23909196

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.