What is the role of nilotinib in the treatment of Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL)?

Updated: Oct 26, 2020
  • Author: Karen Seiter, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Nilotinib is a TKI that has a higher binding affinity and selectivity for the ABL kinase than imatinib. [51] Nilotinib has 20 to 50 times the inhibitory activity against imatinib-sensitive CML cell lines relative to imatinib. In a phase II study in patients with relapsed/refractory Ph+ ALL, complete responses were reported in 24% of patients treated with nilotinib. [51]  

Although nilotinib is approved in the relapsed/refractory setting there are few trials of nilotinib in combination with chemotherapy for newly diagnosed Ph+ ALL. Kim et al reported on 90 patients (ages 17 to 71 years) who received induction treatment with vincristine, daunorubicin, prednisolone, and nilotinib. After achieving complete hematologic remission, subjects received either 5 courses of consolidation, followed by 2-year maintenance with nilotinib, or allogeneic stem cell transplantation. The CR rate was 91% and the cumulative MR5 rate was 94%. The 2-year relapse-free survival rate was 72% and the 2-year overall survival rate was 72%. [52]  

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