Newly diagnosed low‑risk pediatric B‑cell ALL treatment with short blinatumomab courses

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

All enrolled low‑risk B‑cell ALL patients receive a 14‑day course of blinatumomab as early intensification replacing the historical CAT+ intensification, followed by two courses of high‑dose methotrexate (3 g/m²) for consolidation and a second 14‑day blinatumomab course after consolidation. Bone marrow MRD will be monitored by both flow cytometry and IgH NGS, with Day 60 marrow added after the first blinatumomab course. Patients with deep NGS MRD negativity may omit the usual Reinduction‑2 and receive a shortened, chemo‑light maintenance schedule, while others receive the standard longer maintenance. Maintenance cycles are reduced in number and include planned one‑week rest periods after each course for safety monitoring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Must meet all items below:

1. Age older than 1 year and younger than 18 years.
2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
3. Diagnosis of B-ALL by immunophenotyping.
4. Low risk group

Exclusion Criteria:

Should be excluded in the presence of any item below:

1. T-ALL
2. I/HR B-ALL group
3. sIgM+
4. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
5. Philadelphia chromosome positive ALL (Ph-ALL)
6. ALL evolved from chronic myeloid leukemia (CML).
7. Down's syndrome, or major congenital or hereditary disease with organ dysfunction
8. Secondary leukemia
9. Known underlying congenital immunodeficiency or metabolic disease
10. Congenital heart disease with cardiac insufficiency.
11. 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)

Where it's running

• Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
  Tianjin, Tianjin Municipality, China Recruiting
• Anhui Medical University Second Affiliated Hospital
  Hefei, Anhui, China Not yet recruiting
• Anhui Provincial Children's Hospital
  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

Study contacts

• Principal investigator: Xiaofan Zhu, MD — Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
• Study coordinator: Xiaofan Zhu, MD
• Email: xfzhu@ihcams.ac.cn
• Phone: + 86 22 23909001

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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.