臨床研究等提出・公開システム

Japanese

Date of registration	July. 15, 2026
Last modified on	July. 15, 2026
Trial ID	jRCT2071260059

Scientific Title	A Phase II Investigator-Initiated Clinical Trial Evaluating the Safety and Efficacy of Pitavastatin in Myelofibrosis Patients Treated with JAK Inhibitors
Public Title	Phase II Investigator-Initiated Clinical Trial of Pitavastatin Therapy for Myelofibrosis

Contact for Scientific Queries	Name	Shimoda Kazuya
	Affiliation	University of Miyazaki Hospital
	Address	5200 Kihara, Kiyotake-cho, Miyazaki-shi, Miyazaki 889-1692, Japan
	Telephone	+81-985-85-9121
	E-mail	kshimoda@med.miyazaki-u.ac.jp
Contact for Public Queries	Name	Shide Kotaro
	Affiliation	University of Miyazaki Hospital
	Address	5200 Kihara, Kiyotake-cho, Miyazaki-shi, Miyazaki 889-1692, Japan
	Telephone	+81-985-85-9121
	E-mail	koutaro_shide@med.miyazaki-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Sept. 16, 2026
Target sample size		24
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with a confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) according to the diagnostic criteria of the 2017 revised 4th edition of the WHO Classification or the 5th edition of the WHO Classification (2022). Patients who have been receiving a JAK inhibitor for at least 12 weeks at the time of enrollment for the treatment of myelofibrosis. Patients who demonstrate at least Grade 1 (MF-1) bone marrow fibrosis on a screening bone marrow biopsy, based on the bone marrow fibrosis grading system defined in the 2017 revised 4th edition of the WHO Classification.
	Exclusion Criteria	Patients who received HMG-CoA reductase inhibitors (statins) within the 12 weeks prior to the registration date following a diagnosis of myelofibrosis, and patients currently receiving HMG-CoA reductase inhibitors. Patients with hereditary muscle disorders (e.g., muscular dystrophy) or a family history of such disorders. Patients with a history of drug-induced myopathy. Patients with myasthenia gravis or a history of myasthenia gravis.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Myelofibrosis (MF)
Intervention(s)		The investigational product will be administered orally once daily.
Health Condition(s) Keyword		Primary Myelofibrosis (PMF),Post-Polycythemia Vera Myelofibrosis (post-PV MF),Post-Essential Thrombocythemia Myelofibrosis (post-ET MF)
Intervention(s) Keyword		Oral Administration
Health Condition(s) Code		D055728
Intervention(s) Code		D000284
Primary Outcome(s)		Proportion of participants who achieved a reduction of at least one grade in bone marrow fibrosis score at Week 36 compared with baseline.
Secondary Outcome(s)		Proportion of participants who achieved a reduction of at least one grade in bone marrow fibrosis score at Weeks 24 and 48 compared with baseline. Proportion of participants who achieved a reduction of at least one grade in bone marrow fibrosis score at any time point after treatment initiation compared with baseline. Proportion of participants with improvement in hemoglobin levels at Weeks 24, 36, and 48 after treatment initiation. Proportion of participants who met the Gale criteria for transfusion independence at Weeks 24, 36, and 48 after treatment initiation. Proportion of participants with a platelet count >= 100,000 /uL at Weeks 24, 36, and 48 after treatment initiation. Change in spleen volume from baseline at Weeks 24, 36, and 48 after treatment initiation. Change in total symptom score (MPN-SAF TSS) from baseline at Weeks 24, 36, and 48 after treatment initiation. Change in splenomegaly, as assessed by spleen length below the left costal margin, from baseline at Weeks 24, 36, and 48 after treatment initiation. Incidence of adverse events. Incidence of adverse events for which a causal relationship to the investigational product cannot be ruled out (adverse drug reactions). Incidence of serious adverse events for which a causal relationship to the investigational product cannot be ruled out (serious adverse drug reactions). Dose of JAK inhibitor. Comparison of efficacy-related endpoints, including bone marrow fibrosis score, with those of the registry cohort. Dose of pitavastatin.

Primary Sponsor	none

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Institutional Review Board of the University of Miyazaki
Address	5200 Kihara, Kiyotake-cho, Miyazaki-shi, Miyazaki, Miyazaki
Approval Status	Approval
Date of approval	May. 28, 2026

Name of Certified Review Board	Nippon Medical School Hospital Institutional Review Board
Address	1-1-5 Sendagi,Bunkyo-ku, Tokyo, Miyazaki
Date of approval	May. 28, 2026

Name of Certified Review Board	Institutional Review Board,Ehime University Hospital
Address	454 Shitsukawa, Toon, Ehime, Miyazaki
Date of approval	May. 28, 2026

Name of Certified Review Board	Mie University Hospital, Institutional Review Board
Address	2-174 Edobashi, Tsu-city, Mie, Miyazaki
Date of approval	May. 28, 2026

Name of Certified Review Board	University of Yamanashi Hospital , IRB
Address	1110, Shimokato, Chuo, Yamanashi, Miyazaki
Date of approval	May. 28, 2026

Name of Certified Review Board	Kansai Medical University Hospital Clinical Trial Review Committee
Address	6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Osaka, Miyazaki
Date of approval	May. 28, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none