Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment

COMFORT-I Patient Eligibility

A range of myelofibrosis patients are eligible for COMFORT-I

If you have a patient with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis, irrespective of JAK2 mutation status, and who meets the following criteria, he/she may be eligible for enrollment in COMFORT-I:

Key inclusion criteria	Key exclusion criteria
Male or female, >18 years of age Diagnosis of PMF, PPV-MF, or PET-MF as defined by 2008 WHO* criteria At least 2 prognostic risk factors, as defined by the IWG^† ECOG^‡ performance status of 0 to 3 Palpable spleen length of >5 cm below costal margin No previous treatment with a JAK inhibitor	Life expectancy <6 months Inadequate bone marrow reserve Inadequate liver or renal function Significant bacterial, fungal, parasitic, or viral infection requiring treatment Active malignancy within the past 5 years, excluding specific skin cancers Severe cardiac conditions Splenic irradiation within past 12 months

* World Health Organization.
^† International Working Group. Defined as:

Age >65 yrs
Presence of constitutional symptoms (weight loss, fever, night sweats)
Marked anemia (hemoglobin <10 g/dL)
Leukocytosis (history of WBC >25 x 10⁹/L)
Circulating blasts >1%

^‡ Eastern Cooperative Oncology Group.

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This is an international Web site for the COMFORT-I and COMFORT-II trials. The information on this site is not country-specific and may contain trial information that is different from where you practice. INCB018424 is investigational. Efficacy and safety have not been established. There is no guarantee that this compound will become commercially available.