COMFORT-II Eligibility
A range of myelofibrosis patients are eligible for COMFORT-II
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-II:
| 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†
- Peripheral blood blast count of <10%
- ECOG‡ performance status of 0 to 3
- Palpable spleen length of >5 cm below
costal margin
- Must have been on a stable therapeutic regimen
for >2 weeks before screening, and >4 weeks prior to baseline
- No previous treatment with a JAK inhibitor
|
- Life expectancy <6 months
- Inadequate bone marrow reserve
- History of platelet counts <50,000/µL or
ANC <500/µL, except during previous treatment
for a MPN§ or with cytotoxic therapy
- 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
|