Actively Recruiting
Newly-diagnosed Pediatric Ph-positive B-ALL Protocol
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-09-03
150
Participants Needed
24
Research Sites
270 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective clinical trial evaluates the effectiveness and safety of "chemotherapy-light" regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3/CD19 T cell engager blinatumomab, and the BCL-2 selective inhibitor venetoclax for newly diagnosed pediatric/adolescent patients with Ph+ ALL. The CCCG-Ph+ B-ALL-2025 protocol will be modified as following compared to the CCCG-ALL-2020 protocol
CONDITIONS
Official Title
Newly-diagnosed Pediatric Ph-positive B-ALL Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 1 month to younger 18 years.
- Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.
- Written informed consent of the parents or legally authorized guardian according to local laws and regulations.
You will not qualify if you...
- ALL evolved from chronic myeloid leukemia.
- Known underlying congenital immunodeficiency or metabolic disease.
- Congenital heart disease with cardiac insufficiency.
- Gastrointestinal dysfunction or diseases that may affect drug absorption.
- Severe malnutrition, uncontrolled infections, or serious cardiovascular diseases.
- Significant CNS disorders such as uncontrolled seizures or autoimmune CNS diseases.
- Treatment with glucocorticoids for 14 days or more, targeted inhibitors for more than 7 days within one month before enrollment, or chemotherapy, systemic anticancer therapy, or radiotherapy within 3 months before enrollment (except emergency radiotherapy).
- Significant comorbidities or psychiatric disorders impacting safety, compliance, consent, participation, follow-up, or study results interpretation.
AI-Screening
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Trial Site Locations
Total: 24 locations
1
Anhui Medical University Second Affiliated Hospita
Hefei, Anhui, China
Not Yet Recruiting
2
Chongqing Medical University Affiliated Children's Hospital
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
3
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
4
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Not Yet Recruiting
5
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
6
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
7
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Not Yet Recruiting
8
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
9
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
10
Wuhan Children's Hospital
Wuhan, Hubei, China
Not Yet Recruiting
11
Hunan Children's Hospital
Changsha, Hunan, China
Not Yet Recruiting
12
The Third Xiangya Hospital of the Central South University
Changsha, Hunan, China
Not Yet Recruiting
13
Nanjing Children's Hospital Affiliated to Nanjing Medical University
Nanjin, Jiangsu, China
Not Yet Recruiting
14
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Not Yet Recruiting
15
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
Not Yet Recruiting
16
Qilu Hospital of Shandong University
Jinan, Shandong, China
Not Yet Recruiting
17
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Not Yet Recruiting
18
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
19
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
20
Shenzhen Children's Hospital
Shenzhen, Shenzhen, China
Not Yet Recruiting
21
West China Second University Hospita
Chengdu, Sichuan, China
Not Yet Recruiting
22
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Tianjin, Tianjin Municipality, China
Actively Recruiting
23
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
24
Hong Kong Children's Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Not Yet Recruiting
Research Team
J
Jingliao Zhang, MD
CONTACT
X
Xiaofan Zhu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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