Commack, NYNCT05714072Now EnrollingIRB Ready

Myelofibrosis Due to and Following Polycythemia Vera Clinical Trial in Commack, NY

Access cutting-edge myelofibrosis due to and following polycythemia vera treatment through this clinical trial at a research site in Commack. Study-provided care at no cost to qualified participants.

Sponsored by Memorial Sloan Kettering Cancer Center

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This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related myelofibrosis due to and following polycythemia vera treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Commack

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Commack site if eligible
  4. 4Begin participation

About This Myelofibrosis Due to and Following Polycythemia Vera Study in Commack

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.

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

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
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Commack?

Yes, this clinical trial (NCT05714072) has an active research site in Commack, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Myelofibrosis Due to and Following Polycythemia Vera Treatment Options in Commack, NY

If you're searching for myelofibrosis due to and following polycythemia vera treatment options in Commack, NY, this clinical trial (NCT05714072) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Commack research site is actively enrolling participants for this clinical trial. You'll receive care from experienced myelofibrosis due to and following polycythemia vera specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all myelofibrosis due to and following polycythemia vera clinical trials near you to find additional studies recruiting in your area.

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