New treatment options for children with high-risk B-cell leukemia

Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed for Intermediate/High Risk Childhood B-cell ALL

This study is testing two different treatment options for children with high-risk B-cell leukemia to see which one helps them get better and live longer.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 1800 (estimated)
• Ages: 1 Month to 18 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy, Blinatumomab
• Locations: 26 sites (Hefei, Anhui and 25 other locations)
• Trial ID: NCT06764238 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to improve outcomes for children diagnosed with intermediate- and high-risk B-cell acute lymphoblastic leukemia (B-ALL) by evaluating the efficacy of two treatment approaches: a randomized controlled trial using Blinatumomab and a modified mini-hyperCVD regimen combined with Venetoclax for those who cannot afford Blinatumomab. The study will assess the rates of minimal residual disease (MRD) negativity as a primary endpoint, alongside overall survival and quality of life measures. Additionally, it will incorporate advanced evaluation techniques such as IgH rearrangement NGS MRD and pharmacotyping studies to enhance treatment personalization.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 1 month to 18 years diagnosed with B-cell acute lymphoblastic leukemia.

Not a fit: Patients with low-risk ALL or those with certain underlying health conditions, such as congenital heart disease or secondary leukemia, may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could significantly improve event-free survival and overall survival rates for children with high-risk B-ALL.

How similar studies have performed: Previous studies have shown promising results with similar treatment approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Age older than 1 month to younger than 18 years.
2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
3. Diagnosis of B-ALL by immunophenotyping.

Exclusion Criteria:

1. Low-risk ALL
2. sIgM+
3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
4. ALL evolved from chronic myeloid leukemia (CML).
5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction
6. Secondary leukemia
7. Known underlying congenital immunodeficiency or metabolic disease
8. Congenital heart disease with cardiac insufficiency.
9. Treated with glucocorticoids 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 25 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)
• 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)
• 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)
• Xi'an Northwest Women and Children Hospital — Xi’an, Shanxi, China (Not_yet_recruiting)
• West China Second University Hospital, Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC — Tianjin, Tianjin Municipality, China (Recruiting)
• Chongqing Medical University Affiliated Children's Hospital — Chongqing, China (Not_yet_recruiting)
• Children's Hospital of Fudan University — Shanghai, China (Not_yet_recruiting)
• Shanghai Children's Hospital — Shanghai, China (Not_yet_recruiting)
• Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Not_yet_recruiting)
• Shenzhen Children's Hospital — Shenzhen, China (Not_yet_recruiting)
• Hong Kong Children's Hospital — 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: Jingliao Zhang, MD

Conditions Acute Lymphoblastic Leukemia ALL; Childhood Leukemia, Acute Lymphoblastic; B Cell Acute Lymphoblastic Leukemia; blinatimomab; venetoclax