Newly-diagnosed Pediatric Ph-positive B-ALL Protocol

PHASE3RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

March 28, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

June 30, 2030

Conditions
Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)Childhood Leukemia, Acute Lymphoblastic
Interventions
DRUG

olverembatinib

"All Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen.~OVB is combined with Vincristine and Prednisone (VP) during the first 2 weeks and with blinatumomab during the last 4 weeks of remission induction in this protocol.~Patients will receive blinatumomab for 28 days as induction instead of CAT to improve induction response and avoid toxicity.~All patients will receive two cycles of HDMTX+Blina-14 and 4 times of triple intrathecal therapy (TIT) throughout the consolidation 1 phase.~To decrease the toxicities of high-dose AraC, the dosage will be reduced to 1 g/m2 in the consolidation 2 phase in contrast to 2 g/m2 in 2020 protocol.~Throughout the early Maintenance Therapy, dexamethasone and vincristine combination will be added with either venetoclax or daunorubicin alternatively for five cycles, given after MTX and 6-MP."

Trial Locations (24)

Unknown

NOT_YET_RECRUITING

Anhui Medical University Second Affiliated Hospita, Hefei

NOT_YET_RECRUITING

Chongqing Medical University Affiliated Children's Hospital, Chongqing

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 First Affiliated Hospital, Sun Yat-sen University, Guangzhou

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

The Third Xiangya Hospital of the Central South University, Changsha

NOT_YET_RECRUITING

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

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

Children's Hospital of Fudan University, Shanghai

NOT_YET_RECRUITING

Shanghai Children's Hospital, Shanghai

NOT_YET_RECRUITING

Shenzhen Children's Hospital, Shenzhen

NOT_YET_RECRUITING

West China Second University Hospita, Chengdu

RECRUITING

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

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

Hong Kong Children's Hospital, The Chinese University of Hong Kong, Hong Kong

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER