This study combines two drugs (ruxolitinib and the tyrosine kinase inhibitor, nilotinib) in an attempt to eliminate the CML (Chronic Myeloid Leukemia) stem cell population and thus allow for the deepest and most durable response possible in patients with CML in chronic phase who have achieved a complete hematologic remission (CHR), complete cytogenetic remission (CCyR), and major molecular remission (MMR), but not a complete molecular remission (CMR). The study will look at safety and tolerability of ruxolitinib when combined with nilotinib in a phase I study and will help establish the MTD (Maximum Tolerated Dose) of ruxolitinib when combined with nilotinib. Once the optimal dose of ruxolitinib is established in the phase I setting, a phase II evaluation will seek to establish the efficacy of this combination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Nilotinib 300 mg BID
Ruxolitinib, 10, 15 or 20mg BID
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Maximum Tolerated Dose (MTD) of ruxolitinib when combined with nilotinib
Maximum Tolerated Dose (MTD) of ruxolitinib when combined with nilotinib
Time frame: 2 Years
The number of patients that achieve a Complete Molecular Response (CMR)
CMR is defined as an absence of the BCR-ABL1 transcript by qPCR performed on peripheral blood or bone marrow aspirate.
Time frame: 2 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.