Actively Recruiting
Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-07
1800
Participants Needed
26
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 1 month to younger than 18 years
- Diagnosis of acute lymphoblastic leukemia confirmed by bone marrow morphology
- Diagnosis of B-cell acute lymphoblastic leukemia by immunophenotyping
You will not qualify if you...
- Low-risk acute lymphoblastic leukemia
- sIgM positive status
- Acute leukemias of ambiguous lineage as per WHO or EGIL criteria
- Acute lymphoblastic leukemia evolved from chronic myeloid leukemia
- Down's syndrome or major congenital/hereditary disease with organ dysfunction
- Secondary leukemia
- Known congenital immunodeficiency or metabolic disease
- Congenital heart disease with cardiac insufficiency
- Treatment with glucocorticoids for 14 days or more, ABL kinase inhibitors for over 7 days within one month before enrollment, or any chemotherapy/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: 26 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
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 People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 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
Xiangya Hospital Central South University
Changsha, Hunan, China
Not Yet Recruiting
13
Nanjing Children's Hospital Affiliated to Nanjing Medical University
Nanjing, 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
Xi'an Northwest Women and Children Hospital
Xi’an, Shanxi, China
Not Yet Recruiting
19
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
20
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
21
Chongqing Medical University Affiliated Children's Hospital
Chongqing, China
Not Yet Recruiting
22
Children's Hospital of Fudan University
Shanghai, China
Not Yet Recruiting
23
Shanghai Children's Hospital
Shanghai, China
Not Yet Recruiting
24
Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Not Yet Recruiting
25
Shenzhen Children's Hospital
Shenzhen, China
Not Yet Recruiting
26
Hong Kong Children's Hospital
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
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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