EUCTR2005-005107-42-IT
Active, not recruiting
Not Applicable
A Phase II Multicenter Study on the Treatment of Adult de novo Philadelphia Chromosome Positive Ph Acute Lymphoblastic Leukemia ALL with the Protein Tyrosine Kinase Inhibitor BMS-354825. - GIMEMA Protocol LAL1205
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL ADULTO0 sites48 target enrollmentStarted: January 23, 2007Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL ADULTO
- Enrollment
- 48
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •\- 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.
Investigators
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