Status:
COMPLETED
Nilotinib 300 mg BID in Newly Diagnosed CP-CML Patients to Verify Disappearance of CD34+/Lin-Ph+ Cells
Lead Sponsor:
Niguarda Hospital
Conditions:
Leukemia, Myeloid, Chronic-Phase
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multicentre, single-arm study of nilotinib 300 mg BID in newly diagnosed patients with CP-CML. This study is designed to establish the disappearance of Ph+ stem cells (CD34+/lin-) in BM duri...
Detailed Description
This study is designed to establish the disappearance of Ph+ stem cells (CD34+/lin-) in BM during nilotinib treatment. The primary efficacy endpoint is to measure the rate of CD34+/lin-Ph+ cells in t...
Eligibility Criteria
Inclusion
- Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Ph chromosome (9;22) translocation within 3 months of diagnosis
- Patients Ph negative or with variant translocations by standard cytogenetic analysis but Ph positive by FISH, are eligible as well
- Age ≥ 18 years old (no upper age limit given)
- WHO performance status ≤2
- Normal serum levels ≥ LLN (lower limit of normal) of potassium, magnesium, total calcium corrected for serum albumin or phosphorus, or correctable to within normal limits with supplements, prior to the first dose of study medication
- AST and ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to leukaemia
- Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukaemia
- Total bilirubin ≤ 1.5 x ULN, except know Mb Gilbert
- Serum lipase and amylase ≤ 1.5 x ULN
- Serum creatinine ≤ 1.5 x ULN
- Written informed consent signed prior to any study procedures being performed
Exclusion
- Pre-treatment with HU for \> 3 months and with imatinib is not permitted
- Prior accelerated phase including clonal evolution or blast crisis
- Contraindication to excipients in study medication
- impaired cardiac function including any of the following:
- LVEF \<45%
- Complete left bundle branch block
- Right bundle branch block plus left anterior hemiblock,bifascicular block
- Use of a ventricular-paced pacemaker
- Congenital long QT syndrome
- Clinically significant ventricular or atrial tachyarrhythmias
- Clinically significant resting bradycardia (\<50 beats per minute)
- QTcF \>450 msec on screening ECG.If QTcF \>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 within 12 months prior to starting nilotinib
- Other clinical significant heart disease (e.g. unstable angina,congestive heart failure,uncontrolled hypertension)
- Acute (i.e. within 1 year of starting study medication) or chronic pancreatitis
- Concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infections,acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol
- Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g.ulcerative disease,uncontrolled nausea,vomiting and diarrhea,malabsorption syndrome,small bowel resection or gastric by-pass surgery)
- Concomitant medications with potential QT prolongation (see link for complete list: http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm)
- Concomitant medications known to be strong inducers or inhibitors of the CYP450 Isoenzyme CYP3A4:see link for complete list (http://medicine.iupui.edu/flockhart/table.htm)
- Patients who have undergone major surgery ≤ 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 women of reproductive potential not employing an effective method of birth control.Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to administration of nilotinib.Post menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential.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
- Treatment with any haematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF) ≤1 week prior to starting 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
- Patients unwilling or unable to comply with the protocol
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01856283
Start Date
March 1 2013
End Date
January 1 2021
Last Update
January 13 2021
Active Locations (17)
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1
A.O. Ospedale S. Antonio
Gallarate, Milano, Italy
2
Ospedale Desio- "Ospedale Civile" di Vimercate, Desio, Carate Brianza, Giussano, Seregno.
Vimercate, Milano, Italy
3
A.O di Circolo di Busto Arsizio
Busto Arsizio, Varese, Italy
4
Ospedali Riuniti Bergamo
Bergamo, Italy