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

Conditions

• Myelofibrosis Due to and Following Polycythemia Vera

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib — DRUG
  10mg BID or 15mg BID
• Abemaciclib — DRUG
  50, 100 and 150 mg

Study Details

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.

Key Dates

Start date

Jan 25, 2023

Status verified

Nov 2025

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

18 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

OTHER

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.

Primary Outcome Measure

Proportion of patients with dose-limiting toxicity (DLT) [ Time Frame: 28 days ]

Central Contacts

• Raajit Rampal, MD, PhD
  646-608-3746
  [email protected]
• Michael Mauro, MD
  646-608-3744

Locations (7)

Find similar trials in Basking Ridge, NJ

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