A Phase III Study of CPI-0610 with or without Ruxolitinib in People with Myelofibrosis

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Full Title

A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

Purpose

Myelofibrosis (MF) is disease that causes scarring of the bone marrow. The spleen also becomes bigger than normal. The investigational drug CPI-0610 may be an effective treatment for MF because it works to prevent cancer cells from growing and making the spleen get bigger.

In this study, researchers are comparing CPI-0610 with ruxolitinib, a standard MF treatment, with ruxolitinib alone in people with MF. Patients will be randomly assigned to receive ruxolitinib with CPI-0610 or with a placebo. Both medications are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have MF with spleen enlargement.
  • Patients may not have previously received treatment with a JAKi or BET inhibitor.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Raajit Rampal at 646-608-3746.

Protocol

21-163

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators