Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

1,800

Participants

Timeline

Start Date

January 3, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

June 30, 2031

Conditions
Acute Lymphoblastic Leukemia ALLChildhood Leukemia, Acute LymphoblasticB Cell Acute Lymphoblastic Leukemia (B-ALL)
Interventions
DRUG

Blinatumomab (Group A)

For Group A I/HR-ALL patients after induction remission phase, continuous 28 days' blinatumomab followed by 3 cycles of high-dose methotrexate (HDMTX) will be applied, subsequently followed by interim continuation, late intensification, and maintenance therapy

DRUG

Venetoclax (nonRand Group)

For I/HR patients non eligible for blinatumomab randomization, venetoclax+ mini-hyperCVD will be applied after PVDL induction, subsequently followed by CAT as intensification, interim continuation, late intensification, and maintenance therapy

DRUG

Blinatumomab (Group B)

For Group B I/HR-ALL patients after induction remission phase: a two 14-day cycles of blinatumomab, alternating with three cycles of HDMTX will be applied, subsequently followed interim continuation, late intensification, and maintenance therapy

Trial Locations (26)

300020

RECRUITING

Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC, Tianjin

Unknown

NOT_YET_RECRUITING

Anhui Medical University Second Affiliated Hospital, Hefei

NOT_YET_RECRUITING

Anhui Provincial Children's Hospital, Hefei

NOT_YET_RECRUITING

Fujian Medical University Union Hospital, Fuzhou

NOT_YET_RECRUITING

Guangzhou Women and Children's Medical Center, Guangzhou

NOT_YET_RECRUITING

Nanfang Hospital, Southern Medical University, Guangzhou

NOT_YET_RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning

NOT_YET_RECRUITING

The Affiliated Hospital of Guizhou Medical University, Guiyang

NOT_YET_RECRUITING

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan

NOT_YET_RECRUITING

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan

NOT_YET_RECRUITING

Wuhan Children's Hospital, Wuhan

NOT_YET_RECRUITING

Hunan Children's Hospital, Changsha

NOT_YET_RECRUITING

Xiangya Hospital Central South University, Changsha

NOT_YET_RECRUITING

Nanjing Children's Hospital Affiliated to Nanjing Medical University, Nanjing

NOT_YET_RECRUITING

Children's Hospital of Soochow University, Suzhou

NOT_YET_RECRUITING

Jiangxi Provincial Children's Hospital, Nanchang

NOT_YET_RECRUITING

Qilu Hospital of Shandong University, Jinan

NOT_YET_RECRUITING

Affiliated Hospital of Qingdao University, Qingdao

NOT_YET_RECRUITING

Xi'an Northwest Women and Children Hospital, Xi’an

NOT_YET_RECRUITING

West China Second University Hospital, Sichuan University, Chengdu

NOT_YET_RECRUITING

Chongqing Medical University Affiliated Children's Hospital, Chongqing

NOT_YET_RECRUITING

Children's Hospital of Fudan University, Shanghai

NOT_YET_RECRUITING

Shanghai Children's Hospital, Shanghai

NOT_YET_RECRUITING

Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine, Shanghai

NOT_YET_RECRUITING

Shenzhen Children's Hospital, Shenzhen

NOT_YET_RECRUITING

Hong Kong Children's Hospital, Hong Kong

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER