RBR-5g38dt招募中未知
Open lable phase II study of metformin activity in patients with primary myelofibrosis, post-polycythemia vera and post-essential thrombocythemia - METFORMF: Metformin for myelofibrosis
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo0 个研究点开始时间: 2019年12月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 —（—）
入选标准
- •Patients over 18 years. Patients who were diagnosed with primary myelofibrosis, post-polycythemia vera and post-essential thombocythemia according to the World Health Organization in 2017, regardless of JAK2 mutation. Patients who are not taking another medication for the treatment of myelofibrosis or who have received treatment for myelofibrosis within 6 weeks prior to study drug initiation. Patients with oral access to the drug. Patients with life expectancy more or equal to 6 months. Palpable spleen measuring 5 cm or more below costal margin. Peripheral blood counts less or equal to 10%. ECOG less or equal to 2. Glomerular filtration rate (GFR) greater or equal to 60mL/min. Adequate liver function (AST or ALT at levels not exceeding 3x the upper limit of normal, total bilirubin at levels not higher than 2x the upper limit of normal). Negative pregnancy test prior to study initiation and agreement on contraceptive use for women of childbearing age.
排除标准
- •Patients with known hypersensitivity and / or prior therapy with metformin or its excipients. Diabetes mellitus requiring use of insulin and another oral antidiabetic agent. Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C (HCV) (except for chronic infections treated or cured for HBV and HCV, which will be accepted). Concomitant use of all herbal supplements during the study (including but not limited to St. John's wort, kava, None, gingko biloba, dehydroepiandrosterone [DHEA], or ginseng) is prohibited. Megestrol acetate (Megace) or medroxyprogesterone if used as an appetite stimulant is allowed. Uncontrolled conditions due to intercurrent illness, including, but not limited to, ongoing or active infection, refractory systemic hypertension, symptomatic congestive heart failure (New York Heart Association [NYHA] class III functional classification), unstable angina pectoris, cardiac arrhythmia, or psychiatric / social disease that would limit compliance with study requirements. Previous neoplasms, except for skin carcinomas for more than 2 years. Pregnant or breastfeeding patients. Any major surgery, extensive radiotherapy, delayed toxicity chemotherapy, biological therapy, or immunotherapy within 6 weeks prior to clinical trial screening. Any prior or concomitant use of another JAK2 inhibitor. Any investigational medication other than study drug in the 6 weeks prior to the first dose of study drug. Use of hydroxyurea, interferon, prednisone, thalidomide, busulfan, lenalidomide, anagrelide within 6 weeks prior to the first dose of study drug. Hematopoietic growth factor receptor agonists (eg erythropoietin (Epo), granulocyte colony stimulating factor (GCSF), romiplostim, eltrombopag) should not be used as they may be associated with increases in spleen size. Growth factors should not have been used for at least 6 weeks before the first dose of study drug.
研究者
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