Philadelphia chromosome-positive acute lymphoblastic leukemia
Conditions
Interventions
Test group:Flumatinib 400mg QD
Control group:Other First- and Second-Generation TKIs
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Must be diagnosed with Ph+ ALL before enrolment; 2. Aged 14-70 years; 3. Have stable haematopoietic reconstitution 90±30 days after receiving allogeneic haematopoietic stem cell transplantation; 4. Achieve complete donor chimerism post-transplant with a chimerism rate >95%; 5. Be in complete remission and MRD-negative during the screening period post-transplant (within 4 weeks before TKI administration); 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 7. Have a creatinine clearance =60 mL/min (according to the Cockcroft-Gault formula); 8. Have AST and ALT =50%; 10. Have a life expectancy >12 weeks; 11. Voluntarily sign an informed consent form and be able to understand and comply with all study requirements;
Exclusion criteria
Exclusion criteria: 1. Recurrence of bone marrow or extramedullary disease after transplantation; 2. initiation of other drug maintenance after transplantation; 3. cytopenia after transplantation: white blood cells <2000/ul, platelets <50000/ul; 4. active grade 3-4 acute graft-versus-host disease or active moderate to severe chronic graft-versus-host disease that cannot be controlled by medication; 5. active autoimmune diseases, such as SLE, rheumatoid arthritis, etc.; 6. currently having clinically significant active cardiovascular diseases, such as uncontrolled arrhythmias, prolonged QTc interval on ECG, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease according to the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 6 months prior to screening; 7. other severe diseases that may limit the patient's participation in this trial (e.g., progressive infections, uncontrolled diabetes, renal failure); 8. known human immunodeficiency virus (HIV) infection or chronic infections of hepatitis B virus (HBV-DNA positive and HBV-DNA test value exceeding the upper limit of normal) or hepatitis C virus (anti-HCV positive and HCV viral load test value exceeding the upper limit of normal) that cannot be controlled by medication; 9. pregnant or breastfeeding women; 10. individuals who cannot understand or comply with;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematologic and non-hematologic adverse events;Relapse-free survival; | — |
Countries
China
Contacts
Public ContactYanmin Zhao
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed