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RECRUITING
NCT06051409
PHASE3

A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.

Sponsor: Ascentage Pharma Group Inc.

View on ClinicalTrials.gov

Summary

A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of Olverembatinib combined with chemotherapy versus Imatinib combined with chemotherapy in subjects with newly diagnosed Ph+ALL.

Official title: A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Imatinib Combined With Chemotherapy in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2023-08-31

Completion Date

2028-10-31

Last Updated

2024-11-07

Healthy Volunteers

No

Conditions

Interventions

DRUG

Olverembatinib

Orally, once every other day (QOD).

DRUG

Imatinib

Orally, once daily (QD).

Locations (14)

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Alfred Health

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Washington, Australia

The First Affiliated Hospitalo of Bengbu Medical School

Bengbu, Anhui, China

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Guangdong Province People's Hospital

Guangdong, Guangzhou, China

Nanfang Hospital of Southern Medical University

Guangdong, Guangzhou, China

Henan Cancer Hospital

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

The first affiliated hospital of Suzhou University

Suzhou, Jiangsu, China

Shanghai Jiao Tong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Institute of blood transfusion of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China