This study is designed to determine the maximal tolerated dose of Ruxolitinib in combination with nilotinib in patients with chronic myeloid leukemia (CML).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Participants will remain on the same dose of nilotinib they have been receiving prior to enrollment on the trial. This will range from 300 mg PO BID to 400 mg PO BID. Dose modifications will not occur, as the purpose of this study is to determine the maximum tolerated dose of ruxolitinib, based on the number of dose.
Dose escalation will follow a 3+3 study design. Dose modifications will not occur, as the purpose of this study is to determine the maximum tolerated dose, based on the number of dose limiting toxicities seen at a specific dose.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Phase I: Maximum Tolerated Dose (MTD)
Maximum tolerated dose (MTD) of ruxolitinib with nilotinib. Dose escalation will follow a 3+3 study design. If 2 or more participants within a cohort experience a dose limiting toxicity (DLT), then the MTD will have been exceeded and the preceding dose level will be evaluated as the MTD. A minimum of 6 participants must be evaluated at the dose level in order for it to be declared as the MTD. Dose limiting toxicity is defined as: * Any non-hematological toxicity ≥ grade three, excluding any untreated nausea, vomiting, diarrhea or fatigue that occurs during the first 56 days of therapy. * Grade three thrombocytopenia with active bleeding or grade four thrombocytopenia or febrile neutropenia (ANC \<500 cells/µL and fever \> 101.0 F (38.5C)). * Any treatment related grade five toxicity (i.e., death).
Time frame: Average of 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.