Primary Or Secondary (Post-PV MF or Post-ET-MF) Myelofibrosis (MF) With Intermediate Or High-Risk TP53 Wild-Type (TP53 WT) Who Are Relapsed Or Refractory to Janus Kinase (JAK) - Inhibitor Treatment
Conditions
Brief summary
Part A: The proportion of subjects achieving a ≥35% spleen volume reduction from Baseline to Week 24, as assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scan., Part B: The proportion of subjects in each arm achieving SVR of ≥ 35% at Week 24 by MRI/CT scan (central review)
Detailed description
Part A: Proportion of subjects with a reduction in total symptom score, Part A: To determine the duration of reduction of spleen volume, Part A: To determine the need for red blood cell (RBC) transfusion, Part A: The proportion of subjects who have RBC transfusion independence at week 24, Part A: To determine complete and partial remission of treated subjects, Part A: To determine time to death from any cause in treated subjects, Part A: To determine the pharmacokinetic/pharmacodynamic (PK/PD) profile of KRT-232, Part B: The proportion of subjects with reduction from Baseline to Week 24 in the total symptom score, Part B: Time from randomization to death from any cause, Part B: Progression free survival (PFS): time from randomization to either first occurrence of disease progression or death due to any cause, Part B: The proportion of subjects in each arm achieving spleen volume reduction, Part B: Time from initial spleen volume reduction until the first occurrence of disease progression, Part B: The proportion of subjects who have red blood cell transfusion independence at week 24
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: The proportion of subjects achieving a ≥35% spleen volume reduction from Baseline to Week 24, as assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scan., Part B: The proportion of subjects in each arm achieving SVR of ≥ 35% at Week 24 by MRI/CT scan (central review) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Proportion of subjects with a reduction in total symptom score, Part A: To determine the duration of reduction of spleen volume, Part A: To determine the need for red blood cell (RBC) transfusion, Part A: The proportion of subjects who have RBC transfusion independence at week 24, Part A: To determine complete and partial remission of treated subjects, Part A: To determine time to death from any cause in treated subjects, Part A: To determine the pharmacokinetic/pharmacodynamic (PK/PD) profile of KRT-232, Part B: The proportion of subjects with reduction from Baseline to Week 24 in the total symptom score, Part B: Time from randomization to death from any cause, Part B: Progression free survival (PFS): time from randomization to either first occurrence of disease progression or death due to any cause, Part B: The proportion of subjects in each arm achieving spleen volume reduction, Part B: Time from initial spleen volume reduction until the first occurrence of disease progressi | — |
Countries
Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, Italy, Lithuania, Poland, Portugal, Romania, Spain