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

Not Recruiting

Trial ID: NCT00952289


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

Stanford Investigator(s)

Caroline Berube
Caroline Berube

Clinical Associate Professor, Medicine - Hematology

Jason Gotlib

Professor of Medicine (Hematology)


Inclusion Criteria:

   - 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)

Exclusion Criteria:

   - 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

   - Subjects with severe cardiac conditions

   - Subjects who have had splenic irradiation within 12 months


drug: Ruxolitinib

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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