Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL

This is an interventional treatment trial for Acute Leukemia focused on measuring acute lymphoblastic leukemia, flumatinib Read More

Inclusion Criteria:

1. Patients aged 18 to 65 years, male or female;
2. Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABL positive and/ or FISH positive) acute lymphoblastic leukemia; Patients will be diagnosed according to morphologic,immunologic, cytogenetic and molecular(MICM) criteria, including bone marrow morphology, immunophenotype, cytogenetic and molecular genetic (BCR/ABL gene, qualitative and quantitative analysis) examination.
3. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2;
4. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN;
5. Cardiac color Doppler ultrasound ejection fraction ≥ 45%;
6. Subject has provided written informed consent prior to any screening procedure;

Exclusion Criteria:

1. Lymphoid blast crisis of chronic myelocytic leukemia (CML);
2. Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and/or radiotherapy, except for appropriate pre-treatment);
3. Patients with clinical manifestations of central or extramedullary invasion of leukemia at diagnosis;
4. Identification of T315I mutation;
5. Concurrent participation in another clinical study with an investigational medical product;
6. Any concurrent severe and/or uncontrolled medical condition, which could, in the opinion of the investigator, compromise participation in the study;
7. History of neurological or psychiatric disorders, including epilepsy or dementia;
8. Major surgery within 4 weeks or failure to recover from previous surgery;
9. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention;
10. Female patients who are pregnant or breast feeding or patients of childbearing potential and male patients whose sexual partner(s) are women of childbearing potential not willing to use a highly effective method of contraception;
11. Clinically significant, uncontrolled or active cardiovascular disease, specifically including, but not restricted to: any history of myocardial infarction, stroke, or revascularization; unstable angina or transient ischemic attack within 6 months prior to enrolment; congestive heart failure within 6 months prior to enrolment or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards; history of clinically significant (as determined by the treating physician) atrial arrhythmia; any history of ventricular arrhythmia; any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism;Uncontrolled hypertension;
12. Active known positive HIV serology;
13. Active serious infection not controlled by oral or intravenous antibiotics;
14. Patients with known allergies or contraindications to the study drug;
15. Patients with bleeding disorders unrelated to ALL.