NCT06764238RecruitingPhase 2/3
Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol
Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed for Intermediate/High Risk Childhood B-cell ALL
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 1800 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 3 Jan 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- NCT number
- NCT06764238
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 1800
- From 3 Jan 2025 to the primary completion date, 31 Dec 2029
- 27 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 1 month to 18 years · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| The Third Xiangya Hospital of the Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Hunan Children's Hospital Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| West China Second University Hospital, Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| Chongqing Medical University Affiliated Children's Hospital Coordinator of this site? Confirm its status | Chongqing | China | Not yet recruiting |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Guangzhou Women and Children's medical center Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Not yet recruiting |
| Anhui Provincial Children's Hospital Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Anhui Medical University Second Affiliated Hospital Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| Jiangxi Provincial Children's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| Nanjing Children's Hospital Affiliated to Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| The People's Hospital of Guangxi Zhuang Autonomous Region Coordinator of this site? Confirm its status | Nanning | China | Not yet recruiting |
| Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Not yet recruiting |
| Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanghai Children's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Children's Hospital Of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shenzhen Children's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Not yet recruiting |
| Children's Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Not yet recruiting |
| Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Wuhan Children's Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Union Hospital of Tongji Medical College Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Xi'an Northwest Women and Children Hospital Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| Hong Kong Children's Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.