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

ConditionMyelofibrosis Due to and Following Polycythemia Vera

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

Ruxolitinib
Drug
10mg BID or 15mg BID
Abemaciclib
Drug
50, 100 and 150 mg

Treatment groups

18 Participants

are divided into 1 treatment group

Group A: Ruxolitinib plus AbemaciclibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

28 days

Secondary outcomes

overall response rate (ORR)

Response assessment will be according to the 2013 International Working Group (IWG) criteria.

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Eli Lilly and Company

Collaborator

Incyte Corporation