New drug combo hopes to improve myelofibrosis treatment
NCT ID NCT05714072
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This early-phase trial is testing whether adding abemaciclib to the standard drug ruxolitinib is safe and effective for people with myelofibrosis, a type of bone marrow cancer. The study will enroll 18 adults who have been on ruxolitinib for at least 12 weeks. Researchers will monitor for side effects and measure how well the combination controls the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ruxolitinib and abemaciclib
- What this could lead to
- If it works, this could offer a new treatment option for people with myelofibrosis who are already on ruxolitinib.
- What could go wrong
- This is a very early phase 1 trial with only 18 participants, so safety and effectiveness are not yet proven. The drug combo may cause side effects or not work better than existing treatments.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2023
- Expected to finish
-
Jan 2027
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 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: * Patients with PMF or post-PV/ET MF requiring therapy and intermediate-1, -2 or high risk disease by the Dynamic International Prognostic Scoring System (DIPSS) , DIPSS-plus MIPSS7021 or MIPSS70-plus v2.0 if PMF and by the Myelofibrosis Secondary to PV and ET - Prognostic Model (MYSEC-PM) if post-PV/ET MF * Treated with ruxolitinib for ≥12 weeks with a stable dose for the preceding ≥4 weeks. Patients must be on a dose of ruxolitinib of 10mg or 15mg BID at the time of screening. * Evidence of inadequate response to ruxolitinib: Patients must have palpable splenomegaly ≥5 cm below the left costal margin at study entry AND/OR active MPN symptoms, as defined by the presence of one symptom score ≥5 or two symptom scores ≥3 using the screening symptom form * Age ≥ 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. * Life expectancy of at least 24 weeks. * The patient has adequate organ function for all of the following criteria: ° Hematologic * ANC ≥1.5 × 10\^9/L * Platelets ≥75 × 10\^9/L * Hepatic * Total bilirubin ≤1.5 × ULN * Patients with Gilbert's syndrome with a total bilirubin \>2.0 times ULN and direct bilirubin within normal limits are permitted. * ALT and AST ≤3 × ULN * Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to start of therapy. A washout period of at least 21 days is required between last chemotherapy dose and start of combination therapy (with the exception of hydroxyurea, which may be continued until the day before dosing begins). Patients should not receive hydroxyurea while on treatment. * Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization * The effects of ruxolitinib and abemaciclib on the developing human fetus are unknown. To be eligible for the study, female subjects of childbearing potential (and their male partners) and men (and female partners) enrolled in the study should use two methods of effective contraception (hormonal and barrier method of birth control; abstinence) prior and during the study and also continue to use contraception for 4 months after completion of ruxolitinib and abemaciclib administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of ruxolitinib and Abemaciclib administration. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Prior therapy with CDK4/6 inhibitors. * The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study. * Concomitant treatment with other investigational agents for therapy of MF * Splenic irradiation within the 4 months preceding study treatment initiation. * Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy. * Patients with active CNS leukemia. * Inability to swallow pills or GI conditions that would be expected to impair intestinal absorption. * History of allergic reactions attributed to ruxolitinib, abemaciclib or compounds of similar chemical or biologic composition. * The patient has active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment. * Patients with ≥ 10% circulating or bone marrow blasts. * Pregnancy and lactation. * The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea). * The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. * Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A that cannot be discontinued. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/; medical reference texts such as the Physicians' Desk Reference may also provide this information. * Unwillingness to be transfused with blood components. * Inability to comprehend or unwilling to sign the informed consent form (ICF). * Other conditions that, in the opinion of the investigator, may compromise the achievement of the objectives of the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Myelofibrosis due to and following polycythemia vera are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
7 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Memorial Sloan Kettering Basking Ridge
RECRUITINGBasking Ridge, New Jersey, 07920, United States
-
Memorial Sloan Kettering Bergen
RECRUITINGMontvale, New Jersey, 07645, United States
-
Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
-
Memorial Sloan Kettering Monmouth
RECRUITINGMiddletown, New Jersey, 07748, United States
-
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
-
Memorial Sloan Kettering Suffolk - Commack
RECRUITINGCommack, New York, 11725, United States
-
Memorial Sloan Kettering Westchester
RECRUITINGEast White Plains, New York, 10604, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Pens and vouchers: can small rewards boost participation in blood cancer research?
- Can a new pill shrink the spleen in myelofibrosis?
- Can a Dual-Action pill tame bone marrow tumors?
- Can a new pill shrink the spleen in myelofibrosis?
- Can a daily pill shrink the spleen in myelofibrosis?
- Can a new daily pill shrink the spleen and ease myelofibrosis symptoms?