Education and Training
COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial
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).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Ruxolitinib
- drug: Placebo
Eligibility
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)
inhibitor
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
cancers.
- Subjects with severe cardiac conditions
- Subjects who have had splenic irradiation within 12 months
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting