Clinical Research Directory
Browse clinical research sites, groups, and studies.
Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
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).
Official title: Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
3000
Start Date
2025-03-03
Completion Date
2033-06
Last Updated
2025-08-26
Healthy Volunteers
No
Conditions
Interventions
Blinatumomab
All LR-B-ALL patients will be treated with 14 days of blinatumomab (Blina-14) as early intensification to replace CAT+ (historically given in LR-B-AL with MRD19\>0.1% in the 2020 protocol). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment.
Reinduction-2 omission
Reinduction-2 will be omitted for patients with NGS-MRD46\<10\^-6 who have receive the two courses of Blina-14.
Chemo-light Maintenance 2
Patients with FCM-MRD19\<0.01% and IgH rearrangement NGS MRD 46\<10\^-6 will receive chemo-light maintenance-2 with 4 cyles of 8-week course of MTX + 6MP (totally 32 weeks).
Locations (27)
Anhui Medical University Second Affiliated Hospital
Hefei, Anhui, China
Anhui Provincial Children's Hospital
Hefei, Anhui, China
Chongqing Medical University Affiliated Children's Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Wuhan Children's Hospital
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
The Third Xiangya Hospital of the Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Nanjing Children's Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Xi'an Northwest Women and Children Hospital
Xi’an, Shanxi, China
Shenzhen Children's Hospita
Shenzhen, Shenzhen, China
West China Second University Hospital
Chengdu, Sichuan, China
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Tianjin, Tianjin Municipality, China
Hong Kong Children's Hospital
Hong Kong, Hong Kong, Hong Kong