Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors

Running, not enrolling · Phase 2

Conditions studied: Chronic Phase Chronic Myeloid Leukemia, Chronic Myeloid Leukemia, Chronic Phase

In brief

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).

Key facts

Study ID: NCT03610971
Run by: H. Lee Moffitt Cancer Center and Research Institute
People needed: 24
Starts: 2019-11-19
Expected to finish: 2026-10-01
Last updated by the study team: 2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Willing and able to give informed consent
Diagnosed with CML in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR-ABL protein.
Must have a documented history of attempting only one prior TKI discontinuation under the guidance of a treating physician
Must have met ALL the following criteria prior to first attempt to discontinue their TKI:
Stable molecular response (MR4; <0.01% IS) for > 2 years (allowance for a 2 week variance), as documented on at least 4 tests, performed at least 3 months apart. If any results are >0.05% IS, tests must have been repeated within 1 month and be less than 0.01% IS and stable.
Treatment with one of the following FDA approved TKI; imatinib, dasatinib, nilotinib or bosutinib, at any dose for a minimum of approximately 3 years (allowance of a 4 week variance) prior to discontinuing TKIs
Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed)
Must have relapsed (defined as loss of major molecular response (MMR), RQ-PCR for BCR-ABL > 0.1% IS after first attempted discontinuation of TKI
After first failed TFR attempt, must have a minimum duration of 1 year on a TKI, and must plan to remain on this same TKI for a minimum of 12 months during the combination treatment phase
Current TKI must be the same as the TKI being taken prior to the initial TFR attempt (e.g., if patient is on imatinib prior to first TFR attempt, they should be on imatinib at time of enrollment on this study)
Eastern Cooperative Oncology Group (ECOG) performance status 0-3
Must have a RQ-PCR for BCR-ABL less than 0.0032% IS (MR4.5) reported by the trial designated central lab at time of study enrollment
Must adhere to all study contraception guidelines

You may not qualify if…

History of accelerated or blast phase CML
History of TKI resistance
A second malignancy requiring active treatment
Have previously received treatment with a JAK inhibitor.
Platelet count less than 100 × 10\^9/L or an absolute neutrophil count of less than 1 × 10\^9/L or Hemoglobin less than 8 g/dL
AST and ALT ≥ 3 times the institutional upper limit of normal (ULN)
Creatinine ≥ 2 times ULN
Total bilirubin ≥ 1.5 times ULN or >3.0 x the ULN with Gilbert Syndrome (unless direct bilirubin is within normal limits)
Pregnant or lactating
Unable to comply with lab appointments schedule and patient response outcome assessments
Another investigational drug within 4 weeks of enrollment
Any serious medical or psychiatric illness that could, in the investigator's opinion, interfere with the completion of treatment according to this protocol
Have undergone a prior allogeneic transplant
Screening 12-lead ECG showing a baseline corrected QT interval >500msec (patients with a pacemaker will still be eligible with QTc>500msec)

Where it is running

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 — 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

Full record on ClinicalTrials.gov

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