Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
View:
⁃ Must meet all items below:
• Age older than 1 year and younger than 18 years.
• Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
• Diagnosis of B-ALL by immunophenotyping.
• Low risk group
Locations
Other Locations
China
Hunan Children's Hospital
NOT_YET_RECRUITING
Changsha
The Third Xiangya Hospital of the Central South University
NOT_YET_RECRUITING
Changsha
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
West China Second University Hospital
NOT_YET_RECRUITING
Chengdu
Chongqing Medical University Affiliated Children's Hospital
NOT_YET_RECRUITING
Chongqing
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
Guangzhou Women and Children's Medical Center
NOT_YET_RECRUITING
Guangzhou
Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
Anhui Medical University Second Affiliated Hospital
NOT_YET_RECRUITING
Hefei
Anhui Provincial Children's Hospital
NOT_YET_RECRUITING
Hefei
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Jiangxi Provincial Children's Hospital
NOT_YET_RECRUITING
Nanchang
Nanjing Children's Hospital Affiliated to Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
The People's Hospital of Guangxi Zhuang Autonomous Region
NOT_YET_RECRUITING
Nanning
Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Children's Hospital of Fudan University
NOT_YET_RECRUITING
Shanghai
Shanghai Children's Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Shenzhen Children's Hospita
NOT_YET_RECRUITING
Shenzhen
Children's Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
RECRUITING
Tianjin
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Wuhan Children's Hospital
NOT_YET_RECRUITING
Wuhan
Xi'an Northwest Women and Children Hospital
NOT_YET_RECRUITING
Xi’an
Hong Kong Special Administrative Region
Hong Kong Children's Hospital
NOT_YET_RECRUITING
Hong Kong
Contact Information
Primary
Xiaofan Zhu, MD
xfzhu@ihcams.ac.cn
+ 86 22 23909001
Backup
Jingliao Zhang, MD
zhangjingliao@ihcams.ac.cn
+86 22 23909196
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2033-06
Participants
Target number of participants: 3000
Treatments
Experimental: NGS MRD46 ≥ 10^-6
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 and Maintenance-2 will be given in full doses
Experimental: MRD19≥ 0.01% and NGS MRD46 < 10^-6
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 will be omitted, but Maintenance-2 will be given in full doses
Experimental: MRD19 < 0.01% and NGS MRD46 < 10^-6
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 will be omitted, and 5 cycles of Maintenance-2 will be omitted
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China