Zhang Li, Department of Hematology, Henan Cancer Hospital
In 2006, Hausen started the development of flumatinib, a 2nd generation bcr/abl tyrosine kinase inhibitor. After clinical studies on the efficacy, safety, tolerability and pharmacokinetic characteristics of flumatinib in a total of 185 patients with chronic phase, accelerated phase and acutely changed phase chronic granulocytes in phase I and II, it was found to be safe and effective with few side effects. To expand the number of cases and increase the persuasiveness of the data, the Multicenter, Randomized, Open Phase III Clinical Trial to Evaluate the Efficacy and Safety of Flumatinib Versus Imatinib in the Chronic Phase of Newly Diagnosed Chronic Granulomatous Leukemia is being conducted.
Inclusion criteria: Male/female patients aged 18-75 years with Philadelphia chromosome-positive chronic granulomatous chronic phase diagnosed for the first time within 6 months. Control group: free of charge for 1 year on Synovial. Trial group: free flumatinib for 1 year.
Free tests: trial-related routine blood tests, blood smear and bone marrow smear tests, cytogenetic tests, molecular tests, electrocardiogram, chest X-ray, echocardiogram, urine routine, blood biochemistry, physical examination and physical status assessment, as well as necessary tests that are required according to the judgment of the study physician when trial-related clinical indications arise during the course of the trial.
Trial unit: Henan Cancer Hospital (specific person in charge Zhang Li 13,203,729,690)
Hospital of Hematology, Chinese Academy of Medical Sciences (group leader unit)
People’s Hospital of Peking University
The Third Seventh Hospital of the Chinese People’s Liberation Army
General Hospital of the Chinese People’s Liberation Army
Qilu Hospital of Shandong University
Affiliated Hospital of Qingdao University Medical College
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
The First Affiliated Hospital of Xinjiang Medical University
The First Affiliated Hospital of the Fourth Military Medical University
Tangdu Hospital of the Fourth Military Medical University of the Chinese People’s Liberation Army
The Second Hospital of Hebei Medical University
The Second Affiliated Hospital of Xi’an Jiaotong University School of Medicine
Southern Hospital of Southern Medical University
Union Hospital of Fujian Medical University
Xiamen University First Hospital
Shanghai Ruijin Hospital
Shanghai Changhai Hospital
The First Hospital of Zhejiang University Medical College
The First Hospital of Suzhou University
Changzhou First People’s Hospital
Jiangsu Subei People’s Hospital
West China Hospital of Sichuan University
The Second Affiliated Hospital of the Third Military Medical University
The First Hospital of Jilin University
The First Hospital of China Medical University