Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT01134120
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) as defined by the World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms and meet the following additional sub-type specific criteria:
A. PV: has failed or is intolerant of standard therapies or refuses to take standard medications
B. ET: has failed or is intolerant of standard therapies or refuses to take standard medications
C. MF (patients with MF must meet at least one of the following):
i. has intermediate or high-risk MF according to the Lille scoring system; or
ii. has symptomatic MF with spleen greater than 10 cm below left costal margin; or
iii. has post-polycythemic MF; or
iv. has post-ET MF
* Have a quantifiable JAK2 V617F mutation
* Have discontinued all previous approved therapies for myeloproliferative disorders, including any chemotherapy, immunomodulating therapy (for example, thalidomide, interferon-alpha), immunosuppressive therapy (for example, corticosteroids greater than 10 mg/day prednisone or equivalent), radiotherapy, and erythropoietin, thrombopoietin, or granulocyte colony stimulating factor for at least 14 days and recovered from the acute effects of therapy. Hydroxyurea used to control blood cell counts is permitted at study entry if the subject has been maintained on a stable dose for at least 4 weeks. Low-dose acetylsalicylic acid (aspirin) is permitted as well
Exclusion Criteria:
* Have received treatment within 14 days of the initial dose of study drug with an experimental agent that has not received regulatory approval for any indication
* Are currently being treated with agents that are metabolized by CYP3A4 with a narrow therapeutic margin (for example, alfentanil, cyclosporine, diergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) or CYP2B6 (for example, cyclophosphamide, ifosfamide, tamoxifen, efavirenz, propofol, methadone, and bupropion)
* Are currently being treated with warfarin or one of its derivatives which is known to alter levels of protein C or protein S. An exception to this criterion will be allowed for patients with a prior history of Budd-Chiari Syndrome who are being treated with warfarin or one of its derivatives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01134120
Study Brief:
Protocol Section:
NCT01134120