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New treatment option for Myelofibrosis Due to and Following Polycythemia Vera
Official title A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis
ClinicalTrials.gov ID: NCT05714072
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, being studied as a potential treatment for myelofibrosis due to and following polycythemia vera.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is being done to see if the combination of ruxolitinib and abemaciclib is a safe and effective treatment for people with primary or post-polycythemia vera/essential thrombocythemia myelofibrosis.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with PMF or post-PV/ET MF requiring therapy and intermediate-1, -2 or high risk disease by the Dynamic International Prognostic Scoring...
- 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...
- Evidence of inadequate response to ruxolitinib: Patients must have palpable splenomegaly ≥5 cm below the left costal margin at study entry AND/OR...
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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 people of childbearing potential (and their male partners) and men (and female partners)...
- Ability to understand and the willingness to sign a written informed consent document.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.