Tests blinatumomab and venetoclax in children with intermediate or high risk B-cell leukemia
Tests blinatumomab schedules and venetoclax in children with newly diagnosed B-cell acute lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol
Key facts
- Where
- Changsha, Chengdu, Chongqing, Fuzhou, Guangzhou, Guiyang, Hefei, Jinan, Nanchang, Nanjing, Nanning, Qingdao, Shanghai, Shenzhen, Suzhou, Tianjin, Wuhan, and Xi’an, ChinaSee the 26 sites
- Phase
- Phase 2/3
Where in China
- Hunan Children's HospitalChangsha, ChinaNot yet recruiting
- The Third Xiangya Hospital of the Central South UniversityChangsha, ChinaNot yet recruiting
- Xiangya Hospital Central South UniversityChangsha, ChinaNot yet recruiting
- West China Second University Hospital, Sichuan UniversityChengdu, ChinaNot yet recruiting
- Chongqing Medical University Affiliated Children's HospitalChongqing, ChinaNot yet recruiting
- Fujian Medical University Union HospitalFuzhou, ChinaNot yet recruiting
- Guangzhou Women and Children's medical centerGuangzhou, ChinaNot yet recruiting
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaNot yet recruiting
- The Affiliated Hospital of Guizhou Medical UniversityGuiyang, ChinaNot yet recruiting
- Anhui Medical University Second Affiliated HospitalHefei, ChinaNot yet recruiting
- Anhui Provincial Children's HospitalHefei, ChinaNot yet recruiting
- Qilu Hospital of Shandong UniversityJinan, ChinaNot yet recruiting
- Jiangxi Provincial Children's HospitalNanchang, ChinaNot yet recruiting
- Nanjing Children's Hospital Affiliated to Nanjing Medical UniversityNanjing, ChinaNot yet recruiting
- The People's Hospital of Guangxi Zhuang Autonomous RegionNanning, ChinaNot yet recruiting
- Affiliated Hospital of Qingdao UniversityQingdao, ChinaNot yet recruiting
- Children's Hospital Of Fudan UniversityShanghai, ChinaNot yet recruiting
- Shanghai Children's HospitalShanghai, ChinaNot yet recruiting
- Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of MedicineShanghai, ChinaNot yet recruiting
- Shenzhen Children's HospitalShenzhen, ChinaNot yet recruiting
- Children's Hospital of Soochow UniversitySuzhou, ChinaNot yet recruiting
- Institute of Hematology and Blood Diseases Hospital, CAMS & PUMCTianjin, ChinaTaking people
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaNot yet recruiting
- Union Hospital of Tongji Medical College Huazhong University of Science and TechnologyWuhan, ChinaNot yet recruiting
- Wuhan Children's HospitalWuhan, ChinaNot yet recruiting
- Xi'an Northwest Women and Children HospitalXi’an, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06764238
- Record updated
- 23 July 2026
- Original description
Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I/HR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I/HR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore:Read full original descriptionShow less
Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed for Intermediate/High Risk Childhood B-cell ALL
Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I/HR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I/HR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore:
1. The efficacy of two randomized Blinatumomab application scheme on I/HR-ALL as determined by MRD negatvitiy rate. 2. The efficacy of modified mini-hyperCVD + Venetoclax in I/HR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.
Inclusion: Age older than 1 month to younger than 18 years; Diagnosis of acute lymphoblastic leukemia by bone marrow morphology; Diagnosis of B-ALL by immunophenotyping.
Exclusion: 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); Down's syndrome, or major congenital or hereditary disease with organ dysfunction; Known underlying congenital immunodeficiency or metabolic disease; Congenital heart disease with cardiac insufficiency; Low-risk ALL; sIgM+; Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria; ALL evolved from chronic myeloid leukemia (CML); Secondary leukemia.