Evaluation of efficacy and safety of standard chemotherapy in combination with Nilotonib in patients of 55 years and older with Philadelphia chromosome positive Acute Lymphoblastic Leukemia.
- Conditions
- Philadelphia chromosome positive Acute Lymphoblastic Leukemia inelderly patients (55 years and older)MedDRA version: 14.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022855-46-IT
- Lead Sponsor
- Azienda ULSS 12 veneziana
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 55
1. Male or female patients > 55 years
2. Philadelphia chromosome- or BCR-ABL positive acute lymphoblastic
leukemia
3. Not previously treated except with corticosteroids or single dose
vincristine (three doses cyclophosphamide accepted)
4. With or without documented CNS involvement
5. WHO performance status < 2
6. Normal serum levels > LLN (lower limit of normal) of potassium,
magnesium, total calcium corrected for serum albumin; or corrected to within normal limits with supplements, prior to the first dose of study medication7. Signed written inform consent
8. Molecular evaluation for BCR-ABL performed
9. Willingness of male subjects whose sexual partners are women of child-bearing potential (WOCBP), to use an effective form of
contraception (pearl index < 1%), such as complete sexual abstinence, combined oral contraceptive, hormone IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide or surgical sterilisation (vasectomy) in male patients during the study and at least 6 months thereafter. WOCBP are defined as sexually mature women who have notundergone a hysterectomy or surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months).
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 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
1. Patient previously treated with tyrosine kinase inhibitors
2. Known impaired cardiac function, including any of the following:
• LVEF < 45%
• Complete left bundle branch block
• Right bundle branch block plus left anterior hemiblock, ifascicular
block
• Use of a ventricular-paced pacemaker
• Congenital long QT syndrome
• History of or presence of clinically significant ventricular or atrial
tachyarrhythmias
• Clinically significant resting bradycardia (< 50 beats per minute)
• QTcF>450 msec on screening ECG. If QTc > 450 msec and electrolytes are not within normal ranges before nilotinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF criterion.
• Myocardial infarction with 12 months prior to starting nilotinib
• Other clinical significant heart disease (e.g. unstable angina,congestive heart failure, uncontrolled hypertension)
3. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
4. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or known infection with Hepatitis B or C
5. Treatment with any, other investigational agent or participating in another trial within 30 days prior to entering this study
6. Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the institutional upper limit of normal or > 5 times ULN if considered due to leukemia
7. Total bilirubin > 2 fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert / M. Meulengracht
8. Concurrent severe diseases which exclude the administration of
therapy
9. Past history of acute or chronic pancreatits
10. Patients unwilling or unable to comply with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of a Nilotinib-based induction and consolidation therapy;Secondary Objective: To evaluate the safety of a Nilotinib-based induction and consolidation therapy;Primary end point(s): Rate of patients without events at 12 months;Timepoint(s) of evaluation of this end point: After 12 months of treatment. During or after 3rd year of the whole trial
- Secondary Outcome Measures
Name Time Method