Find Acute Lymphoblastic Leukemia (ALL) Clinical Trials Near You
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)
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Meet the WHO 2016 Ph chromosome or BCR/ABL1 positive Ph+ALL diagnostic and typing criteria for acute lymphoblastic leukemia. This is a newly diagnosed Ph+ALL.
• Expected survival of at least 3 months.
• ECOG ≤ 2.
• Adequate organ function.
• Use effective contraception during treatment and for at least three months after the last dose of the study drug, and male patients may not donate sperm.
• Pregnancy test results of serum samples obtained within 7 days prior to the first dosing of a fertile female subject were negative.
• Understand and voluntarily sign the informed consent approved by the Ethics Committee (EC) and voluntarily complete the study procedure and follow-up examination.
Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Alfred Health
RECRUITING
Melbourne
Royal Perth Hospital
RECRUITING
Perth
Royal North Shore Hospital
RECRUITING
St Leonards
China
The First Affiliated Hospitalo of Bengbu Medical School
NOT_YET_RECRUITING
Bengbu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Xinqiao Hospital of Army Medical University
NOT_YET_RECRUITING
Chongqing
Guangdong Province People's Hospital
NOT_YET_RECRUITING
Guangdong
Nanfang Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangdong
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
NOT_YET_RECRUITING
Shanghai
The first affiliated hospital of Suzhou University
RECRUITING
Suzhou
Institute of blood transfusion of Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Tianjin
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology