Treatment Free Remission After Combination Therapy with Ruxolitinib Plus Tyrosine Kinase Inhibitors
- Conditions
- Chronic Phase Chronic Myeloid LeukemiaChronic Myeloid Leukemia, Chronic Phase
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria:<br><br> - Willing and able to give informed consent<br><br> - Diagnosed with CML in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2)<br> variants that give rise to the p210 BCR-ABL protein.<br><br> - Must have a documented history of attempting only one prior TKI discontinuation<br> under the guidance of a treating physician<br><br> - Must have met ALL the following criteria prior to first attempt to discontinue their<br> TKI:<br><br> - Stable molecular response (MR4; <0.01% IS) for > 2 years (allowance for a 2<br> week variance), as documented on at least 4 tests, performed at least 3 months<br> apart. If any results are >0.05% IS, tests must have been repeated within 1<br> month and be less than 0.01% IS and stable.<br><br> - Treatment with one of the following FDA approved TKI; imatinib, dasatinib,<br> nilotinib or bosutinib, at any dose for a minimum of approximately 3 years<br> (allowance of a 4 week variance) prior to discontinuing TKIs<br><br> - Has been on any number of TKIs, but has not been resistant to any TKI (changes<br> made for intolerance are allowed)<br><br> - Must have relapsed (defined as loss of major molecular response (MMR), RQ-PCR for<br> BCR-ABL > 0.1% IS after first attempted discontinuation of TKI<br><br> - After first failed TFR attempt, must have a minimum duration of 1 year on a TKI, and<br> must plan to remain on this same TKI for a minimum of 12 months during the<br> combination treatment phase<br><br> - Current TKI must be the same as the TKI being taken prior to the initial TFR attempt<br> (e.g., if patient is on imatinib prior to first TFR attempt, they should be on<br> imatinib at time of enrollment on this study)<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status 0-3<br><br> - Must have a RQ-PCR for BCR-ABL less than 0.0032% IS (MR4.5) reported by the trial<br> designated central lab at time of study enrollment<br><br> - Must adhere to all study contraception guidelines<br><br>Exclusion Criteria:<br><br> - History of accelerated or blast phase CML<br><br> - History of TKI resistance<br><br> - A second malignancy requiring active treatment<br><br> - Have previously received treatment with a JAK inhibitor.<br><br> - Platelet count less than 100 × 10^9/L or an absolute neutrophil count of less than 1<br> × 10^9/L or Hemoglobin less than 8 g/dL<br><br> - AST and ALT = 3 times the institutional upper limit of normal (ULN)<br><br> - Creatinine = 2 times ULN<br><br> - Total bilirubin = 1.5 times ULN or >3.0 x the ULN with Gilbert Syndrome (unless<br> direct bilirubin is within normal limits)<br><br> - Pregnant or lactating<br><br> - Unable to comply with lab appointments schedule and patient response outcome<br> assessments<br><br> - Another investigational drug within 4 weeks of enrollment<br><br> - Any serious medical or psychiatric illness that could, in the investigator's<br> opinion, interfere with the completion of treatment according to this protocol<br><br> - Have undergone a prior allogeneic transplant<br><br> - Screening 12-lead ECG showing a baseline corrected QT interval >500msec (patients<br> with a pacemaker will still be eligible with QTc>500msec)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 12 Month Treatment Free Remission (TFR)
- Secondary Outcome Measures
Name Time Method Adverse Events Possibly Related to Study Treatment