Post-Essential Thrombocythaemia Myelofibrosis, Post-Polycythaemia Vera Myelofibrosis, Primary Myelofibrosis
Conditions
Brief summary
1. Percentage of patients who achieve at least 35% reduction in spleen volume from baseline as measured by MRI (preferred) or CT scan at Week 24., 2. Percentage of patients with at least 50% reduction in TSS from baseline at Week 24 (as defined by the Myeloproliferative Neoplasm Symptom Assessment Form [MPN‐SAF TSS 2.0] excluding the “tiredness” component)
Detailed description
1. Percentage of patients who self-assess as “very much improved” or “much improved” at Week 24, 2. Time from randomization to the date of death due to any cause, 3. Incidence and severity of TEAEs, including SAEs and deaths, as well as laboratory values and vital signs, including cardiac evaluations from the time of randomization until 30 days after completion of treatment with pacritinib and/or physician's choice therapy
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients who achieve at least 35% reduction in spleen volume from baseline as measured by MRI (preferred) or CT scan at Week 24., 2. Percentage of patients with at least 50% reduction in TSS from baseline at Week 24 (as defined by the Myeloproliferative Neoplasm Symptom Assessment Form [MPN‐SAF TSS 2.0] excluding the “tiredness” component) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients who self-assess as “very much improved” or “much improved” at Week 24, 2. Time from randomization to the date of death due to any cause, 3. Incidence and severity of TEAEs, including SAEs and deaths, as well as laboratory values and vital signs, including cardiac evaluations from the time of randomization until 30 days after completion of treatment with pacritinib and/or physician's choice therapy | — |
Countries
Bulgaria, Czechia, France, Hungary, Italy, Poland, Romania, Spain