Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada
Patients with acute lymphoblastic leukemia and positivity for the breakpoint cluster region-Abelson murine leukemia (BCR-ABL) protein or the Philadelphia chromosome have a poor prognosis with standard chemotherapy. The prognosis seemed to improve following the adition of imatinibe, a BCR-ABL inhibitor, to the treatment but still a substantial amount of patients relapse or progress during treatment.
Nilotinib is a BCR-ABL inhibitor more potent than imatinib. It has been shown to be effective against most of the cells that bear mutations of the BCR-ABL protein leading to resistance to imatinibe.
The investigators' hypothesis is that the addition of nilotinib to a standard chemotherapy for acute lymphoblastic leukemia (ALL) will translate into more rapid BCR-ABL reduction and effectiveness against imatinib-resistant clones leading to less relapses and better survival.
400mg, Oral, Bid, Daily for three years
Inclusion Criteria: Diagnosis of Acute Lymphoblastic Leukemia (ALL) BCR-ABL positive positive by PCR (central Lab) No previous treatment for ALL except for corticoids and cyclophosphamide less than 600 mg/m2 Must be able to swallow tablets Lab results within normal limits (Potassium, Calcium, Magnesio, Phosphorus, Transaminases, Alkaline Phosphatase, Bilirrubine, Amylase, Lypase) Exclusion Criteria: Heart disease Interval QTc Fridericia > 480 msec Coumadin use Pregnancy PS = 4 Previous medical history of etilism or/and pancreatic disease