Actively Recruiting
A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-11-18
18
Participants Needed
7
Research Sites
205 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with primary myelofibrosis or post-polycythemia vera/essential thrombocythemia myelofibrosis requiring therapy and classified as intermediate-1, -2 or high risk by approved scoring systems
- Treated with ruxolitinib for at least 12 weeks with a stable dose for the last 4 weeks, currently on 10mg or 15mg twice daily
- Evidence of inadequate response to ruxolitinib with palpable spleen enlargement 5 cm or more below the left costal margin and/or active symptoms
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status of 0, 1 or 2
- Life expectancy of at least 24 weeks
- Adequate organ function including hematologic and hepatic parameters
- Recovery from chemotherapy and radiotherapy effects with required washout periods
- Use of two effective contraception methods during and 4 months after treatment for participants and their partners
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Prior therapy with CDK4/6 inhibitors
- Participation in another experimental treatment trial within 30 days or 5 half-lives before randomization
- Use of other investigational agents for myelofibrosis
- Splenic irradiation within 4 months before study start
- Incomplete recovery from major surgery toxicity or complications
- Active central nervous system leukemia
- Inability to swallow pills or gastrointestinal absorption issues
- Allergy to ruxolitinib, abemaciclib, or similar compounds
- Active systemic bacterial, fungal, or viral infections
- 10% or more circulating or bone marrow blasts
- Pregnancy or breastfeeding
- Serious or uncontrolled preexisting medical conditions that may affect study participation
- History of specific serious cardiac conditions
- Use of medications that strongly affect CYP3A metabolism which cannot be stopped
- Unwillingness to receive blood transfusions
- Inability or unwillingness to provide informed consent
- Other conditions that may compromise study objectives in investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
R
Raajit Rampal, MD, PhD
CONTACT
M
Michael Mauro, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
1
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