COVID Update: Masks are still required in health care settings, even if you’re fully vaccinated. Also, Scripps does not provide COVID-19 tests for asymptomatic patients. See FAQs.
Investigational Combination Therapy for Treatment Naïve Myelofibrosis Patients
Marin Xavier, MD
This is a randomized, placebo controlled study to compare the safety and effectiveness of adding a PI3K inhibitor (INCB050465) to standard treatment for patients with Myelofibrosis.
Be diagnosed with Primary Myelofibrosis(PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF).
Be 18 years or older.
Be willing to avoid pregnancy, fathering a child, or donating sperm.
Patients must not:
Have been previously treated with a JAK inhibitor or any drug that inhibits PI3K (For example: Idelalisib, Duvelisib, Buparlisib, Copanlisib, and Umbralisib).
Have used any experimental drug therapy for Myelofibrosis or any other standard drug used for Myelofibrosis with the exception of Ruxolitinib, within 3 months of starting the study.
Have any splenic radiation in the past 6 months.
Have an active HBV, HCV, HIV, or other viral infection
Be currently breastfeeding or pregnant.
Eligible patients will be randomized to receive standard treatment with Ruxolitinib or the investigational combination of Ruxolitinib plus the study drug INCB050465.
This study is double-blind which means neither you or the study physician will know which group you are randomized to receive. Bone Marrow Biopsy is required at screening and every 6 months while on trial.
This is a crossover study so you may have the option of receiving the investigational combination (Ruxolitinib + INCB050465) after 6 months. Study participation will last up to 2.5years.
Search NCT04551066 at https://clinicaltrials.gov website for more information.