Status:
COMPLETED
COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial
Lead Sponsor:
Incyte Corporation
Conditions:
MPN (Myeloproliferative Neoplasms)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 Mye...
Detailed Description
Patients with spleen growth of greater than 25% based on an increase in spleen volume from Baseline were eligible for early unblinding, and for patients on placebo, cross over to ruxolitinib prior to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT00952289
Start Date
August 1 2009
End Date
October 1 2015
Last Update
March 12 2018
Active Locations (112)
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1
Birmingham, Alabama, United States
2
Scottsdale, Arizona, United States
3
Baldwin Park, California, United States
4
Bellflower, California, United States