Single nucleotide polymorphism association with response and toxic effects in patients with Ph+ CP-CML treated with bosutinib after relapse or intolerance to previous treatment. - BOSTRO

Fundación PETHEMA para el tratamiento de la leucemia y el linfoma0 sites50 target enrollmentFebruary 9, 2015

Overview

No summary available.

Registry

who.int

Start Date

February 9, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Fundación PETHEMA para el tratamiento de la leucemia y el linfoma

•1\.Signed and dated informed consent form.
•2\.Patients with chronic phase of Ph\+ CML who showed failure to previous TKI treatment. Failure is defined as BCR\-ABL \>10% by qRT\-PCR (IS) at 3 months of treatment initiation.
•3\.ECOG Performance Status of 0 or 1\.
•4\.Recovered to Grade 0\-1, or to baseline, from any toxicities of prior treatment, other than alopecia
•5\.Able to take daily oral capsules
•6\.Adequate bone marrow function: a. Absolute neutrophil count \> 1000/mm3 (\>1000 x109/L) b. Platelets ? 100,000/mm3 (\>100 x109/L) absent any platelet transfusions during the preceding 14 days.
•7\.Adequate hepatic, and renal function:
•oAST/ALT ? 2\.5 × upper limit of normal (ULN) or ? 5 × ULN if attributable to liver involvement of leukemia
•oTotal bilirubin ? 1\.5 × ULN
•oCreatinine ? 1\.5 × ULN

•1\.Subjects with Philadelphia chromosome and bcr\-abl negative CML.
•2\. Overt leptomeningeal leukemia. Subjects must be free of CNS involvement for a minimum of 2 months. Subjects with symptoms of CNS involvement must have a diagnostic lumbar puncture prior to study enrollment.
•3\.Subjects with extramedullary disease only.
•4\.Prior stem cell transplantation.
•5\.Major surgery within 14 days or radiotherapy within 7 days before the first dose of Bosutinib (recovery from any previous surgery should be complete before day 1\)
•6\.A history of a clinically significant ventricular arrhythmia, congenital or acquired prolonged QT interval, a baseline QTcF \> 0\.47 sec (average of triplicate readings) or unexplained syncope, uncontrolled or symptomatic congestive heart failure (CHF) within 3 months, or myocardial infarction (MI) within 6 months.
•7\.Concomitant use of or need for medications known to prolong the QT interval
•8\.Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval
•9\.Recent (within 30 days of study entry) or ongoing clinically significant gastrointestinal disorder (e.g., malabsorption, short bowel syndrome, bleeding, or grade \>1 diarrhea, nausea or emesis lasting more than 2 days, despite adequate medical therapy)
•10\.Pregnant or breastfeeding women