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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT04655118
Eligibility Criteria:
Cohorts 1-3
Key Inclusion Criteria:
* Adults ≥18 years of age
* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
* Adequate hematologic, hepatic, and renal functions
* MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0
* Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and \< 50 x 10\^9/L
Key Exclusion Criteria:
* Prior treatment with any BTK or BMX inhibitors
* Prior treatment with JAKi within 28 days prior to study treatment
* Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
Cohort 5
Key Inclusion Criteria:
* Adults ≥18 years of age
* Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results
* Subject must have moderate-to-severe symptoms
Key Exclusion Criteria:
* Prior treatment with any BTK or BMX inhibitors
* Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib
* Diagnosis with another myeloproliferative disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04655118
Study Brief:
Protocol Section:
NCT04655118