Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia
Status:
Completed
Trial end date:
2018-12-31
Target enrollment:
Participant gender:
Summary
This is the study to test combination regimen of Nilotinib and Ruxolitinib therapy for the
treatment of patients with Philadelphia positive chronic myeloid leukemia (CML) or acute
lymphoblastic leukemia (ALL) who is resistant to multiple tyrosine kinase inhibitor therapies
with BCR-ABL kinase inhibition activity. Ruxolitinib is a tyrosine kinase inhibitor blocking
alternative pathway independent of BCR-ABL mediated pathway, thus having a potential to
overcome tyrosine kinase inhibitor resistance in Philadelphia positive CML or ALL patients.
Phase I study will be conducted to define a recommended phase II dose (RPTD) and phase II
study will examine the hypothesis that combinational approach will increase response rate of
resistant CML/ALL patients, thus evaluating efficacy of the combination regimen.