COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial

Trial ID or NCT#



not recruiting iconNOT RECRUITING


This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).

Official Title

A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor INCB018424 Tablets Administered Orally to Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF) according to the 2008 World Health Organization criteria* Subjects with myelofibrosis requiring therapy must be classified as high risk OR intermediate risk level 2 according to the prognostic factors defined by the International Working Group* Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3* Subjects who have not previously received treatment with a Janus kinase (JAK) inhibitor
Exclusion Criteria:
  1. * Subjects with a life expectancy of less than 6 months* Subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts* Subjects with inadequate liver or renal function* Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy* Subjects with an active malignancy over the previous 5 years except specific skin cancers.* Subjects with severe cardiac conditions* Subjects who have had splenic irradiation within 12 months


Caroline Berube
Caroline Berube
Clinical Associate Professor, Medicine - Hematology
Jason Gotlib
Professor of Medicine (Hematology)

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Cancer Clinical Trials Office