Acute Lymphoblastic Leukemia Clinical Trial
Official title:
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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