The purpose of this study is to determine if adding Ruxolitinib to a Tyrone Kinase Inhibitor (TKI), prior to a second attempt at stopping a TKI will lead to prolonged treatment free remission (TFR).
All participants will have a confirmed diagnosis of chronic phase chronic myeloid leukemia (CML) and must have previously attempted to discontinue TKI therapy. All participants must be restarted on a TKI at the time of relapse in order to be eligible for this trial. After completion of 12 cycles of combination therapy, eligible participants will remain in the TFR phase of the study for up to 36 months, and will have central polymerase chain reaction (PCR) testing during the first 24 months. Therefore, the total duration of the trial will be approximately 48 months (12 months on combination treatment phase + 36 months in the TFR phase).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Ruxolitinib: 15 mg by mouth (PO) twice a day (BID).
The BCR-ABL TKIs that will be used include imatinib, dasatinib, nilotinib or bosutinib.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory -Winship Cancer Institute
Atlanta, Georgia, United States
Memorial Sloan Kettering - Bergen
Montvale, New Jersey, United States
Roswell Park Comprehensive Cancer Center
12 Month Treatment Free Remission (TFR)
TFR rate after completion of 12 cycles of combination therapy.
Time frame: 12 months post 12 cycles of treatment
Adverse Events Possibly Related to Study Treatment
Establish the adverse event profile of ruxolitinib in combination with BCR-ABL TKIs: Adverse Events (AEs) and Serious Adverse Events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0, that are possibly, probably, or definitely related to study treatment.
Time frame: Up to 30 days post treatment, approximately 13 months per participant
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Buffalo, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering
New York, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States