Yükleniyor... / Loading...
Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase
Bu çalışma, Nilotinib adlı ilacı, yeni tanı almış, kronik fazda Philadelphia kromozomu ve/veya BCR-ABL pozitif kronik miyeloid lösemi (chronic myeloid leukaemia) olan yetişkinlerde inceliyor. Çalışmaya, sitogenetik olarak doğrulanmış kronik faz kronik miyeloid lösemi tanısı olan hastalar alınmıştır. Çalışma Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
+280
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Patients with diagnosis of CP-CML with cytogenetic confirmation of Philadelphia (Ph) chromosome * Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR are also eligible * WHO performance status 0-2 * Laboratory assessments within normal limits * Written informed consent prior to any study procedures being performed Exclusion Criteria: * Known impaired cardiac function * History of acute or chronic pancreatitis * Impaired gastrointestinal function or disease that may alter the absorption of study drug * Concomitant medications with potential QT prolongation, or known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8) * 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 females of reproductive potential not employing an effective method of birth control. 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 Other protocol-defined inclusion/exclusion criteria may apply