Myelofibrosis Myelofibrosis,MF
Conditions
Interventions
None listed
Sponsors
Shimoda Kazuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed with primary myelofibrosis according to the diagnostic criteria for the WHO Classification, 4th edition (2017) or WHO Classification, 5th edition (2022). Patients diagnosed with post-polycythemia vera myelofibrosis (post PV-MF) or post-essential thrombocytosis myelofibrosis (post ET-MF) according to the diagnostic criteria for the WHO Classification, 4th edition (2008)/ICC. 2)Patients with JAK2, MPL, or CALR gene mutations or patients with none of the three mutations (triple negative). If JAK2 gene mutation is confirmed, MPL and CALR tests are not mandatory. If JAK2 gene mutation is confirmed, MPL and CALR tests are not mandatory. 3)Patients who are newly starting of momelotinib administration. 4)Patients with ECOG performance status of 0, 1, or 2. 5)Patients with a life expectancy of >= 24 weeks from the date of enrollment. 6)Patients aged 18 years or older at the time of obtaining consent. 7)Patients who have received a full explanation of the study and have given their written informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients who have previously been treated with momelotinib. 2)Patients who are unable to obtain appropriate consent due to psychiatric disorders etc. 3)Patients with a history of hypersensitivity to any component of momelotinib 4)Patients who are deemed inappropriate for participation in this study by the Principal Investigator in medical institution (Site Investigator) and the Sub Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rolling transfusion independence rateat 24 weeks (Gale criteria; no RBC transfusions over any 12-week period) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Proportion of subjects who meet the major response criteria of the 2024 revised IWG-ELN criteria for anemia response in MF at 24 weeks after starting momelotinib 2)Proportion of subjects who meet the minor response criteria of the 2024 revised IWG-ELN criteria for anemia response in MF at 24 weeks after starting momelotinib 3)Hemoglobin improvement rate at 24 weeks after starting momelotinib 4)Absolute change from baseline in total symptom score (MPN-SAF TSS) at 24 weeks after starting momelotinib 5)Proportion of subjects with splenomegaly measured by left subcostal length that are =< 50% of baseline at 24 weeks after starting momelotinib 6)Dose of momelotinib 7)Adverse events during momelotinib treatment 8)Leukemia-free survival (LFS) and overall survival (OS) after starting momelotinib treatment 9)Rolling transfusion independence rate at 48 weeks (Gale criteria; no RBC transfusions over any 12-week period) 10)Proportion of subjects who meet the major response criteria of the 2024 revised IWG-ELN criteria for anemia response in MF at 48 weeks after starting momelotinib 11)Proportion of subjects who meet the minor response criteria of the 2024 revised IWG-ELN criteria for anemia response in MF at 48 weeks after starting momelotinib 12)Hemoglobin improvement rate at 48 weeks after starting momelotinib | — |
Contacts
Public Contactkoutaro Shide
University of Miyazaki, Faculty of Medicine
Outcome results
None listed