Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed for Intermediate/High Risk Childhood B-cell ALL

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:

• Age older than 1 month to younger than 18 years.

• Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.

• Diagnosis of B-ALL by immunophenotyping.

Locations
Other Locations
China
Hunan Children's Hospital
NOT_YET_RECRUITING
Changsha
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
West China Second University Hospital, Sichuan University
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 Hospital
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
Jingliao Zhang, MD
zhangjingliao@ihcams.ac.cn
+86 22 23909196
Backup
Xiaofan Zhu, MD
xfzhu@ihcams.ac.cn
+ 86 22 23909001
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2031-06
Participants
Target number of participants: 1800
Treatments
Experimental: Group A
After PVDL+CAT induction remission phase, patients randomized to Group A will be subjected to consolidation phase with continuous 28 days' blinatumomab followed by 3 cycles of high-dose methotrexate (HDMTX)
Experimental: Group B
After PVDL+CAT induction remission phase, patients randomized to Group B will be subjected to consolidation phase with two 14-day cycles of blinatumomab, alternating with 3 cycles of high-dose methotrexate (HDMTX).
Experimental: NonRandonmized Group
Patients who will not be subjected to blinatomomab randomization, will received PVDL + Venetoclax + mini-hyperCVD as induction phase , subsequently receiving CAT as early intensification.
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov