Treatment of Adult de novo Philadelphia Chromosome Positive Ph Acute Lymphoblastic Leukemia ALL MedDRA version: 6.1 Level: PT Classification code 10000846
Conditions
Interventions
Trade Name: L01X - dasatinib
Product Name: Dasatinib
Product Code: BMS 354825
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: dadatinib
Current Sponsor code: GIMEMA LAL1205
Other descript
Sponsors
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL ADULTO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -- Patients with de novo Ph and/or BCR/ABL ALL within 14 days from diagnosis - Age 8805;18 years old - No prior treatment with any anti-leukemic drugs with the exception of steroids for no more than 14 days including the 7-day pretreatment already scheduled in the protocol - WHO performance status 8804;2 - Absence of central nervous system CNS leukemia - Normal serum level of potassium, total calcium corrected for serum albumin magnesium and phosphorus, or correctable with supplements - ALT and AST 8804;2.5 x ULN upper limit of normal range or 8804;5.0 x ULN if considered due to leukemia - Alkaline phosphatase 8804;2.5 x ULN unless considered to leukemia - Serum bilirubin 8804;2 x ULN - Serum creatinine 8804;3 x ULN - Serum amylase 8804;1.5 x ULN and serum lipase 8804;1.5 x ULN - Normal cardiac function - Written informed consent prior to any study procedures being performed.. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Impaired cardiac function, including any one of the following 61607; LVEF Left Ventricular Ejection Fraction 45 as determined by MUGA scan or echocardiogram 61607; Complete left bundle branch block 61607; Use of a cardiac pacemaker 61607; ST depression of 1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads 61607; Congenital long QT syndrome 61607; History of or presence of significant ventricular or atrial tachyarrhythmia 61607; Clinically significant resting bradycardia 50 beats per minute 61607; QTc 450 msec on screening ECG using the QTcF formula 61607; Right bundle branch block plus left anterior hemiblock, bifascicular block 61607; Myocardial infarction within 3 months prior to starting BMS-354825 61607; Angina pectoris 61607; Other clinically significant heart disease e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen - Impairment of gastrointestinal GI function or GI disease that may significantly alter the absorption of BMS-354825 e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection - Use of therapeutic warfarin - Acute or chronic liver or renal disease considered unrelated to leukemia - Other concurrent severe and/or uncontrolled medical conditions e.g., uncontrolled diabetes, active or uncontrolled infection that could cause unacceptable safety risks or compromise compliance with the protocol - Treatment with any hematopoietic colony-stimulating growth factors e.g., G-CSF, GM CSF 8804;1 week prior to starting study drug - Patients who are currently receiving treatment with any of the medications listed in Appendix F and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix F have the potential to prolong the QT interval. - Patients who have received any anti-leukemic agents and treatments including steroids for more than 14 days including 7 days pretreatment that is part of the protocol - Patients who have received any investigational drug in the last 2 weeks - Patients who have undergone major surgery 8804;2 weeks prior to starting study drug or who have not recovered from side effects of such therapy - Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of BMS-354825 . Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug - Known diagnosis of human immunodeficiency virus HIV infection HIV testing is not mandatory - Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention - Non compliant to oral medication patients. - Central nervous system CNS involvement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to estimate the activity of BMS-354825 in de novo adult Ph ALL patients in terms of complete hematological remission CHR rate with or without Full hematological Recovery- FR ;Secondary Objective: To evaluate treatment toxicity To estimate the rate of cytogenetic responses To estimate the rate of molecular responses To assess disease-free survival DFS To estimate relapse rate To assess overall survival OS .;Primary end point(s): HCR with or without FR rate obtained during the BMS induction treatment, whenever achieved by Day 85. | — |
Countries
Italy
Outcome results
None listed