Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New combo aims to free CML patients from daily pills

NCT ID NCT03610971

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic myeloid leukemia, chronic phase are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering

    New York, New York, 10021, United States

  • Duke University Hospital

    Durham, North Carolina, 27710, United States

  • Emory -Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Memorial Sloan Kettering - Bergen

    Montvale, New Jersey, 07645, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • 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.