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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

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xiangya Hospital Central South University
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ChangshaChinaNot yet recruiting
The Third Xiangya Hospital of the Central South University
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ChangshaChinaNot yet recruiting
Hunan Children's Hospital
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ChangshaChinaNot yet recruiting
West China Second University Hospital, Sichuan University
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ChengduChinaNot yet recruiting
Chongqing Medical University Affiliated Children's Hospital
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ChongqingChinaNot yet recruiting
Fujian Medical University Union Hospital
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FuzhouChinaNot yet recruiting
Nanfang Hospital, Southern Medical University
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GuangzhouChinaNot yet recruiting
Guangzhou Women and Children's medical center
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GuangzhouChinaNot yet recruiting
The Affiliated Hospital of Guizhou Medical University
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GuiyangChinaNot yet recruiting
Anhui Provincial Children's Hospital
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HefeiChinaNot yet recruiting
Anhui Medical University Second Affiliated Hospital
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HefeiChinaNot yet recruiting
Qilu Hospital of Shandong University
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JinanChinaNot yet recruiting
Jiangxi Provincial Children's Hospital
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NanchangChinaNot yet recruiting
Nanjing Children's Hospital Affiliated to Nanjing Medical University
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NanjingChinaNot yet recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
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NanningChinaNot yet recruiting
Affiliated Hospital of Qingdao University
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QingdaoChinaNot yet recruiting
Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaNot yet recruiting
Shanghai Children's Hospital
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ShanghaiChinaNot yet recruiting
Children's Hospital Of Fudan University
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ShanghaiChinaNot yet recruiting
Shenzhen Children's Hospital
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ShenzhenChinaNot yet recruiting
Children's Hospital of Soochow University
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SuzhouChinaNot yet recruiting
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
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TianjinChinaRecruiting
Wuhan Children's Hospital
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WuhanChinaNot yet recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaNot yet recruiting
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
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WuhanChinaNot yet recruiting
Xi'an Northwest Women and Children Hospital
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Xi’anChinaNot yet recruiting
Hong Kong Children's Hospital
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Hong KongHong Kong SAR ChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.