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RecruitingPhase 3NCT07152041

Newly-diagnosed Pediatric Ph-positive B-ALL Protocol

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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

150 participants

Start Date

Mar 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 1 MonthMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment protocol for children newly diagnosed with Philadelphia chromosome-positive (Ph+) B-cell acute lymphoblastic leukemia (a specific type of childhood leukemia driven by a genetic abnormality). The study aims to improve outcomes with targeted therapy. **You may be eligible if...** - The child is older than 1 month and younger than 18 years - The child has been newly diagnosed with Ph-positive or BCR::ABL1-positive B-ALL (a type of leukemia) - A parent or legal guardian has provided written informed consent **You may NOT be eligible if...** - The leukemia developed from a pre-existing condition called CML - The child has a known immune deficiency or metabolic disorder - The child has serious heart, gastrointestinal, or neurological problems - The child received significant steroid or chemotherapy treatment recently - There are other serious health conditions that could affect safety Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGolverembatinib

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.

Locations(24)

Anhui Medical University Second Affiliated Hospita

Hefei, Anhui, China

Chongqing Medical University Affiliated Children's Hospital

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

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

Wuhan, Hubei, China

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

Wuhan, Hubei, China

Wuhan Children's Hospital

Wuhan, Hubei, China

Hunan Children's Hospital

Changsha, Hunan, China

The Third Xiangya Hospital of the Central South University

Changsha, Hunan, China

Nanjing Children's Hospital Affiliated to Nanjing Medical University

Nanjin, Jiangsu, China

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Children's Hospital

Shanghai, Shanghai Municipality, China

Shenzhen Children's Hospital

Shenzhen, Shenzhen, China

West China Second University Hospita

Chengdu, Sichuan, China

Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC

Tianjin, Tianjin Municipality, China

Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC

Tianjin, Tianjin Municipality, China

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

Hong Kong, Hong Kong

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