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:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT02436135
Eligibility Criteria:
Key Inclusion Criteria:
* Individuals must have been on a stable dose of ruxolitinib for at least 4 weeks prior to study entry
* Individuals with PMF, post-PV MF, or post-ET MF classified as high risk or intermediate risk as defined by the Dynamic International Prognostic Scoring System (DIPSS) for PMF or DIPSS Plus, if cytogenetics are available
* Individuals with PMF, post-PV MF, or post-ET MF who are receiving ruxolitinib and meet 2013 Revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria with progressive and relapsed disease, with modifications for progressive disease complete remission (CR), partial remission (PR), or clinical improvement (CI)
* European Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Required screening laboratory values as described in the protocol
* Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions including mandatory prophylaxis for pneumocystis jiroveci pneumonia (PJP)
* Able to understand and willing to sign the informed consent form
Key Exclusion Criteria:
* Individuals on a stable ruxolitinib dose of 5 mg once daily
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing drug-induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver
* Ongoing drug-induced pneumonitis
* Ongoing inflammatory bowel disease
* Ongoing alcohol or drug addiction
* Symptomatic congestive heart failure (New York Heart Association Classification \> Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
* Known hypersensitivity to the study investigational medicinal product (IMP), the metabolites, or formulation excipients
* Unwilling or unable to take oral medication
* Unresolved non-hematologic toxicities from prior therapies that are \> Common terminology Criteria for Adverse Events (CTCAE) Grade 1 (with the exception of alopecia \[Grade 1 or 2 permitted\])
* Pregnant or lactating females
* Cytomegalovirus (CMV): Ongoing infection, treatment, or prophylaxis within the past 28 days
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02436135
Study Brief:
Protocol Section:
NCT02436135