Phase
Condition
N/ATreatment
Imatinib
Olverembatinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Meet the WHO 2016 Ph chromosome or BCR/ABL1 positive Ph+ALL diagnostic and typingcriteria 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 thelast 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 firstdosing of a fertile female subject were negative.
Understand and voluntarily sign the informed consent approved by the EthicsCommittee (EC) and voluntarily complete the study procedure and follow-upexamination.
Exclusion
Exclusion Criteria:
A history of chronic myeloid leukemia and a diagnosis of acute leukemia with chronicmyeloid leukemia.
Clinical manifestations of central nervous system (CNS) leukemia or ALLextramedullary infiltration, except lymphadenopathy or hepatosplenomegaly.
Previous or current clinical CNS diseases.
Autoimmune diseases that may involve the CNS.
Use therapeutic doses of anticoagulants and/or antiplatelet agents but allow lowdoses of anticoagulants to keep central venous lines open.
Use a therapeutic drug that has drug interaction with the investigational drug dueto other diseases within 7 days prior to the first receipt of the investigationaldrug.
Uncontrolled Heart diseases.
Had any VTE in the 6 months prior to randomization, including but not limited todeep vein thrombosis (DVT) or pulmonary embolism.
Use of prohibited drugs.
The presence of any disease or medical condition that is unstable or may affect itssafety or compliance with the study.
Medications known to cause prolonged QT interval.
Active infections requiring systemic treatment.
Disease that severely affects the oral administration and absorption of drugs, or anactive gastrointestinal ulcer.
Contraindications to the use of glucocorticoids, and the researchers judge that theyare not suitable to participate in this study.
Bleeding disorders unrelated to the tumor.
Plan to undergone major surgery.
Allergy to drug ingredients, excipients, or their analogues in the study.
Female subjects who are pregnant or breastfeeding or expect to become pregnantduring the study plan or within 3 months of the last dosing.
Other malignant tumors within 2 years.
Any symptom or illness that may interfere with the evaluation of the efficacy andsafety of the investigational drug, or any other condition or condition that is notappropriate for participation in the study.
Study Design
Study Description
Connect with a study center
Royal North Shore Hospital
St. Leonards, New South Wales
AustraliaActive - Recruiting
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Alfred Health
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Royal Perth Hospital
Perth, Washington 6000
AustraliaActive - Recruiting
The First Affiliated Hospitalo of Bengbu Medical School
Bengbu, Anhui 233000
ChinaSite Not Available
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing 214426
ChinaSite Not Available
Guangdong Province People's Hospital
Guangdong, Guangzhou 510080
ChinaSite Not Available
Nanfang Hospital of Southern Medical University
Guangdong, Guangzhou 510515
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 450003
ChinaSite Not Available
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaSite Not Available
The first affiliated hospital of Suzhou University
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai, Shanghai 200025
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan 610044
ChinaSite Not Available
Institute of blood transfusion of Chinese Academy of Medical Sciences
Tianjin, Tianjin 215127
ChinaSite Not Available

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