Myelofibrosis Due to and Following Polycythemia VeraPhase 1NCT05714072
A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis
A Phase 1 study testing Ruxolitinib and Abemaciclib in people with Myelofibrosis Due to and Following Polycythemia Vera, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis Due to and Following Polycythemia Vera
- What is being tested?
- Ruxolitinib and Abemaciclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Jan 2023to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 18Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Mauro, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Raajit Rampal, MD,PhD, 646-608-3746
- Recruiting
Memorial Sloan Kettering Suffolk - Commack
Commack, New York, 11725
Raajit Rampa, MD, PhD, 646-608-3746
- Recruiting
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604
Raajit Rampal, MD, PhD, 646-608-3746
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Raajit Rampal, MD, PhD, 646-608-3746
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Raajit Rampal, MD, PhD, 646-608-3746
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Raajit Rampal, MD, PhD, 646-608-3746
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Raajit Rampal, MD, PhD, 646-608-3746
About this study
Official title: A Phase I Study of Ruxolitinib Plus Abemaciclib for Patients With Primary or Post-polycythemia Vera/Essential Thrombocythemia Myelofibrosis
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.
- Being tested
- Ruxolitinib, Abemaciclib
- Keywords
- Ruxolitinib, Abemaciclib, 22-075
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
10mg BID or 15mg BID
AbemaciclibDrug
50, 100 and 150 mg
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib plus Abemaciclib | Experimental | 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. Receives: Drug: Ruxolitinib; Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with dose-limiting toxicity (DLT)
Dose-limiting toxicities (DLTs) will be defined based on toxicities observed during the first cycle of the combination treatment. Adverse events (AEs) that are possibly, probably or definitely related to study drug(s) will be scored as toxicities. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 28 days
Secondary outcomes (1)
overall response rate (ORR)
Response assessment will be according to the 2013 International Working Group (IWG) criteria.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start25 Jan 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelofibrosis Due to and Following Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a non-randomized phase 1 clinical trial evaluating the safety and activity of combined ruxolitinib and abemaciclib in patients with primary or post-polycythemia vera/essential thrombocythemia myelofibrosis. Patients will be treated in dose escalation using a 3+3 design.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Raajit Rampal, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714072
- Sponsor's protocol ID
- 22-075
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Ruxolitinib Plus Abemaciclib for Patients With Primary or Post-polycythemia Vera/Essential Thrombocythemia Myelofibrosis
- ClinicalTrials.gov ID
- NCT05714072
- Acronym / sponsor ID
- 22-075
- Keywords
- Ruxolitinib, Abemaciclib, 22-075
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Incyte Corporation
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a non-randomized phase 1 clinical trial evaluating the safety and activity of combined ruxolitinib and abemaciclib in patients with primary or post-polycythemia vera/essential thrombocythemia myelofibrosis. Patients will be treated in dose escalation using a 3+3 design.
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib plus Abemaciclib | Experimental | Drug: Ruxolitinib, Drug: AbemaciclibThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib10mg BID or 15mg BID | Drug | Ruxolitinib plus Abemaciclib |
| Abemaciclib50, 100 and 150 mg | Drug | Ruxolitinib plus Abemaciclib |
Primary outcome
Proportion of patients with dose-limiting toxicity (DLT)
Time frame: 28 days
Dose-limiting toxicities (DLTs) will be defined based on toxicities observed during the first cycle of the combination treatment. Adverse events (AEs) that are possibly, probably or definitely related to study drug(s) will be scored as toxicities. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
1 secondary outcome
overall response rate (ORR)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Related trials for Myelofibrosis Due to and Following Polycythemia Vera
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
RecruitingPhase 1
A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Polycythemia Vera (PV), Myelofibrosis (MF)
Active, not recruitingPhase 2
Extended Access of Momelotinib in Adults With Myelofibrosis
Primary Myelofibrosis
RecruitingPhase 2
Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias
Myelofibrosis, Post-polycythemia Vera Myelofibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Mauro, MD contact
Raajit Rampal principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ruxolitinib and Abemaciclib in people with Myelofibrosis Due to and Following Polycythemia Vera, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raajit Rampal, MD, PhD (646-608-3746, rampalr@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with dose-limiting toxicity (DLT) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.