Actively Recruiting
Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-26
3000
Participants Needed
27
Research Sites
430 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
CCCG-ALL2025 LR-B-ALL plan is designed based on the CCCG-ALL2020 plan. This is a clinical trial using 14 days of blinatumomab (Blina-14) as early intensification after induction therapy and 2nd Blina-14 in consolidation therapy in all newly diagnosed provisional low-risk (LR) pediatric acute lymphoblastic leukemia (ALL) patients, regardless of measurable residual diseases (MRD) status. We will compare the efficacy of chemotherapy combined with Blina-14, comparing to CAT+ intensification or historical regimens. Patients with early remission in depth will receive chemo-light late intensification and maintenance therapy afterwards. Early complete remission in depth and maintenance reduction will be determined by next-generation sequencing (Ig-NGS MRD).
CONDITIONS
Official Title
Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 1 year and younger than 18 years
- Diagnosis of acute lymphoblastic leukemia by bone marrow morphology
- Diagnosis of B-cell acute lymphoblastic leukemia by immunophenotyping
- Classified as low risk group
You will not qualify if you...
- Diagnosis of T-cell acute lymphoblastic leukemia
- Intermediate or high risk B-cell acute lymphoblastic leukemia group
- Positive surface IgM (sIgM+)
- Acute leukemias of ambiguous lineage as defined by WHO or EGIL criteria
- Philadelphia chromosome positive ALL (Ph-ALL)
- ALL evolved from chronic myeloid leukemia
- Down's syndrome or major congenital or hereditary disease with organ dysfunction
- Secondary leukemia
- Known congenital immunodeficiency or metabolic disease
- Congenital heart disease with cardiac insufficiency
- Glucocorticoid treatment for 14 days or more, ABL kinase inhibitors for over 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except emergency radiotherapy to relieve airway compression)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Anhui Medical University Second Affiliated Hospital
Hefei, Anhui, China
Not Yet Recruiting
2
Anhui Provincial Children's Hospital
Hefei, Anhui, China
Not Yet Recruiting
3
Chongqing Medical University Affiliated Children's Hospital
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
5
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Not Yet Recruiting
6
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
7
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Not Yet Recruiting
8
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Not Yet Recruiting
9
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
10
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
11
Wuhan Children's Hospital
Wuhan, Hubei, China
Not Yet Recruiting
12
Hunan Children's Hospital
Changsha, Hunan, China
Not Yet Recruiting
13
The Third Xiangya Hospital of the Central South University
Changsha, Hunan, China
Not Yet Recruiting
14
Xiangya Hospital Central South University
Changsha, Hunan, China
Not Yet Recruiting
15
Nanjing Children's Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
Not Yet Recruiting
16
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Not Yet Recruiting
17
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
Not Yet Recruiting
18
Qilu Hospital of Shandong University
Jinan, Shandong, China
Not Yet Recruiting
19
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Not Yet Recruiting
20
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
21
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
22
Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
23
Xi'an Northwest Women and Children Hospital
Xi’an, Shanxi, China
Not Yet Recruiting
24
Shenzhen Children's Hospita
Shenzhen, Shenzhen, China
Not Yet Recruiting
25
West China Second University Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
26
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Tianjin, Tianjin Municipality, China
Actively Recruiting
27
Hong Kong Children's Hospital
Hong Kong, Hong Kong, Hong Kong
Not Yet Recruiting
Research Team
X
Xiaofan Zhu, MD
CONTACT
J
Jingliao Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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