Clinical Trial Finder

Clinical trial finder

A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.
  • - Hemoglobin Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.
Initial treatment must not begin earlier than the day after the erythrocyte transfusion.
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05714072
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Raajit Rampal
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myelofibrosis Due to and Following Polycythemia Vera
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Ruxolitinib plus Abemaciclib

This will be a phase 1 study with a traditional "3+3" design of combination ruxolitinib (at fixed doses of 10mg BID or 15mg BID) and abemaciclib. There are 3 planned dose levels of abemaciclib: 50, 100 and 150 mg. Cycles will be 4 weeks (28 days) long and DLT window will consist of first cycle.

Interventions

Drug: - Ruxolitinib

10mg BID or 15mg BID

Drug: - Abemaciclib

50, 100 and 150 mg

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

Site Contact

Raajit Rampal, MD,PhD

[email protected]

646-608-3746

Memorial Sloan Kettering Monmouth, Middletown, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

Site Contact

Raajit Rampal, MD, PhD

[email protected]

646-608-3746

Memorial Sloan Kettering Bergen, Montvale, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

Site Contact

Raajit Rampal, MD, PhD

[email protected]

646-608-3746

Commack, New York

Status

Recruiting

Address

Memorial Sloan Kettering Suffolk - Commack

Commack, New York, 11725

Site Contact

Raajit Rampa, MD, PhD

[email protected]

646-608-3746

Memorial Sloan Kettering Westchester, Harrison, New York

Status

Recruiting

Address

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

Site Contact

Raajit Rampal, MD, PhD

[email protected]

646-608-3746

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Raajit Rampal, MD, PhD

[email protected]

646-608-3746

Uniondale, New York

Status

Recruiting

Address

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

Site Contact

Raajit Rampal, MD, PhD

[email protected]

646-608-3746