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

Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia

This protocol will try giving two short 14‑day courses of blinatumomab early and during consolidation for children with newly diagnosed low‑risk B‑cell ALL to allow less intensive later chemotherapy when deep MRD negativity is achieved.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 3000 (estimated)
• Ages: 1 Year to 18 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy, blinatumomab, binatumomab
• Locations: 27 sites (Hefei, Anhui and 26 other locations)
• Trial ID: NCT06882057 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children older than 1 year and younger than 18 years with newly diagnosed low‑risk B‑cell ALL confirmed by marrow morphology and immunophenotyping are eligible.

Not a fit: Children with T‑ALL, intermediate/high‑risk B‑ALL, Ph‑positive disease, Down syndrome, major congenital organ dysfunction, secondary leukemia, known congenital immunodeficiency/metabolic disease, significant recent chemotherapy/radiation, or congenital heart failure are excluded and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce exposure to intensive chemotherapy and shorten maintenance for deeply MRD‑negative low‑risk children while preserving cure rates.

How similar studies have performed: Blinatumomab has shown benefit in MRD‑positive and relapsed B‑cell ALL in prior studies, but using two brief universal early courses plus NGS‑guided chemo de‑escalation in newly diagnosed low‑risk pediatric patients is a relatively new strategy.

Eligibility criteria

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 this trial is running

Hefei, Anhui and 26 other locations

• 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)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (Not_yet_recruiting)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Not_yet_recruiting)
• Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Union Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Wuhan Children's Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• Hunan Children's Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• The Third Xiangya Hospital of the Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Xiangya Hospital Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Nanjing Children's Hospital Affiliated to Nanjing Medical University — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Children's Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• Jiangxi Provincial Children's Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Not_yet_recruiting)
• Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Not_yet_recruiting)
• Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanghai Children's Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Xi'an Northwest Women and Children Hospital — Xi’an, Shanxi, China (Not_yet_recruiting)
• Shenzhen Children's Hospita — Shenzhen, Shenzhen, China (Not_yet_recruiting)
• West China Second University Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC — Tianjin, Tianjin Municipality, China (Recruiting)
• Hong Kong Children's Hospital — Hong Kong, Hong Kong, Hong Kong (Not_yet_recruiting)

Study contacts

• Principal investigator: Xiaofan Zhu, MD — Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
• Study coordinator: Xiaofan Zhu, MD

Conditions Acute Lymphoblastic Leukemia ALL; Childhood Leukemia, Acute Lymphoblastic; B Cell Acute Lymphoblastic Leukemia; blinatumomab; chemo-light