A Phase 3, Multicenter Trial for Pediatric Philadelphia Chromosome-positive B-Acute Lymphoblastic Leukemia -2025 Project

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This prospective clinical trial evaluates the effectiveness and safety of chemotherapy-light regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3/CD19 T cell engager blinatumomab, and the BCL-2 selective inhibitor venetoclax for newly diagnosed pediatric/adolescent patients with Ph+ ALL. The CCCG-Ph+ B-ALL-2025 protocol will be modified as following compared to the CCCG-ALL-2020 protocol

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

⁃ Must meet all items below:

• Age older than 1 month to younger 18 years.

• Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.

• Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.

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
West China Second University Hospita
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 First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
Anhui Medical University Second Affiliated Hospita
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
Nanjin
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
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
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
NOT_YET_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
Hong Kong Special Administrative Region
Hong Kong Children's Hospital, The Chinese University of Hong Kong
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: 2025-03-28
Estimated Completion Date: 2030-06
Participants
Target number of participants: 150
Treatments
Experimental: OVB+Blina+VEN+Chemo-light regimen
All Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen. Cyclophosphamide and asparaginase are totally omitted from the entire treatment to mitigate toxicities.~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. The dosage of AraC will be reduced to 1 g/m2 in the consolidation 2 phase.~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.
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov