New combo aims to free CML patients from daily pills
NCT ID NCT03610971
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding ruxolitinib to a standard tyrosine kinase inhibitor (TKI) can help people with chronic myeloid leukemia (CML) stop their medication for longer. Participants had previously tried stopping a TKI but relapsed. The study enrolls 24 adults and measures how many remain in remission without treatment after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ruxolitinib (Jakafi) plus a tyrosine kinase inhibitor (imatinib, dasatinib, nilotinib, or bosutinib)
- What this could lead to
- If successful, this could help some CML patients stay off daily medication for longer periods, reducing side effects and treatment burden.
- What could go wrong
- This is a small, early-phase study with only 24 participants. The combination may cause more side effects, and not everyone may achieve treatment-free remission.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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24 people
The number who actually took part.
- Started
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Nov 2019
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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David H. Koch Center for Cancer Care at Memorial Sloan Kettering
New York, New York, 10021, United States
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Duke University Hospital
Durham, North Carolina, 27710, United States
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Emory -Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
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Memorial Sloan Kettering - Bergen
Montvale, New Jersey, 07645, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a newer drug outperform the standard for chronic myeloid leukemia?
- Can a new pill rescue patients when standard leukemia drugs stop working?
- Real-World check: Asciminib's performance in Tough-to-Treat CML
- CML drug combo aims for Treatment-Free remission, but trial stalls
- Leukemia patients who failed stopping meds may get another shot at drug-free remission
- New CML drug combo strategy aims for deeper remission without lifelong side effects