Acute lymphoblastic leukemia with Ph-positive
Conditions
Interventions
Age 65 years or less:1.Pretreatment: If patients with WBC = 30000/L or with severe hepatosplenomegaly or lymph node enlargement then should receive Prednisone 1 mg/kg/d, 3-5 days, or the same amount o
Age 65 years or less:2.Induction regimen (4-week FVD regimen): Flumatinib(FM) 600mg Po Qd+ Vindesine(VDS) 4mg/d (D1, 8, 15, 22) + Dexamethasone(DXMS) 20mg/d (D1-4, 8-11, 15-18, 22-25) (bone marrow asp
Age 65 years or less:3. Consolidation therapy (8 weeks, divided into two stages, each stage 4 weeks). CAM regimen [Cyclophosphamide(CTX) 1000mg/m2/d (d1) + Cytarabine(Ara-C) 75 mg/m2/d (d3-6,10-13) +
Age 65 years or less:4.Intensive therapy (1-2 times): Hyper-CVAD-B regimen: MTX 1g/m2 was infused continuously for 24 hours, and Calcium Folinate was given for detoxification per 12 hours. After detox
Age 65 years or less:5.Transplantation: If the minimal residual disease (MRD) of fusion gene is persistent negative, then autologous hematopoietic stem cell transplantation would be selected (ASCT)
otherwise allogeneic hematopoietic stem cell transplantation (allo-HSCT) would be.
Age 65 years or less:6.Maintenance therapy: allo-HSCT: FM 600mg/d lasts for 1 year
ASCT: FVP regimen 28 days/course, lasting for one year: FM 600mg+VDS 4mg (d1)+Prednisone 1mg/kg/d (d1-5).
Age 65 years or less:7.Whole course prophylaxis of central nervous system leukemia(CNSL) : Intrathecal injection (MTX 10 mg + Ara-C 50 mg + DXM 10 mg) was performed at least 12-16 times, and patients
Sponsors
Department of Hematology, The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Male
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 65 years, both male and female; 2. Newly diagnosed patients with Ph+ ALL without treatment; 3. ECOG PS scores(Eastern Cooperative Oncology Group Physical Status)of patients are 0~2; 4. Visceral functional examination of patients meets all the following indicators: Total bilirubin=45% by Cardiac colour Doppler ultrasonography; 6. The pregnancy test of fertile female patients is negative (within 7 days before enrollment); 7. Patients should sign the informed consent of this trial before recruiting.
Exclusion criteria
Exclusion criteria: 1) Patients with chronic myelogenous leukemia progression to lymphoid blast crisis; 2) Patients with prior or ongoing systemic anti-ALL therapy (including but not limited to TKI and/or radiotherapy), other than appropriate pre-treatment; 3) Patients diagnosed with clinical manifestations of leukemia central invasion or extramedullary invasion; 4) Patients with T315I mutation; 5) Patients participate in other clinical studies; 6) According to the investigator's judgment, patients with concomitant diseases which seriously endanger the patient's safety or affect the patient's completion of the study; 7) Patients with previous medical history of neurological or psychiatric disorders, including epilepsy or dementia; 8) Patient had a major operation in 4 weeks or did not recover from the previous operation; 9) Patient with other malignant tumors, unless the other primary cancer is currently stable or does not require active intervention; 10) Patients, who are female of childbearing age or male, including pregnant or breastfeeding women, are unable to use adequate methods of contraception; 11) Patients with clinically significant serious uncontrolled heart disease (including but not limited to a history of myocardial infarction, stroke or revascularization; A history of unstable angina pectoris or transient ischemic attack within 6 months before recruit; A history of congestive heart failure or left ventricular ejection fraction (LVEF) within 6 months before recruit was lower than the normal lower limit of local agency standards; A history of clinically significant atrial arrhythmia, as diagnosed by physician; A history of ventricular arrhythmia; A history of venous thromboembolism, including with deep venous thrombosis or pulmonary embolism with uncontrolled hypertension); 12) Patients diagnosed positive status of human immunodeficiency; 13) Patients with severe and active infections which cannot be controlled by oral or intravenous antibiotics; 14) Patients with known allergies or contraindications to study drugs (apis and/or excipients); 15) Patients took medications or Chinese herbal medicines, which are known to be associated with a potent inhibitor or strong inducer of cytopigment P450(CYP)3A4, within 14 days before the first administration of the study drug; 16) Patients with bleeding disorders not associated with ALL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission state of bone marrow;Remission state of hematology;Disappear of extramedullary invasion;Leukemia-free survival;Overall survival;Cumulative disease rate of relapse;Early mortality rate; | — |
Countries
China
Contacts
Public ContactWang Li
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed