NCT07281781招募中1 期
Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Hepcidin Levels
研究概览
简要总结
This is a phase I/II protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Have a diagnosis of myelofibrosis (MF) according to the 2016 WHO criteria
- •Has a hemoglobin ≤ 10gm/dL at screening
- •Serum ferritin ≥ 100
- •May continue on current MPN treatment, including aspirin, hydroxyurea, interferon-alpha, ruxolitinib, fedratinib, or anagrelide.
- •Peripheral blast count <10% during Screening.
- •Free of other known active or metastatic malignancies other than localized skin cancer.
- •Amenable to blood draws and symptom assessments.
- •Agree to the use of contraceptives. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, should both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug.
排除标准
- •Eastern Cooperative Oncology Group (ECOG) questionnaire score of ≥3
- •Currently pregnant or planning on being pregnant within the study period.
- •Currently taking Momelotinib or Pacritinib (these agents are purported to reduce hepcidin).
- •Currently taking any of the contraindicated medications to Nelfinavir listed in section 13.2
- •Currently breastfeeding.
- •Known uncontrolled active viral or bacterial infection.
- •Known HIV+
- •Significant impairment of major organ or hematopoietic function defined as
- •Serum creatinine clearance less than 30 ml/min (eGFR).
- •Bilirubin more than 1.5 mg/dl except for Gilbert's disease. ALT or AST more than 2X upper normal limit or has radiologic evidence of liver cirrhosis.
- •Platelets < 50 × 10^9/L without transfusions
- •ANC < 0.75 × 10^9/L without growth factors
- •Known history of allergic reaction to nelfinavir.
研究组 & 干预措施
Nelfinavir
Experimental
Given Orally
干预措施: Nelfinavir (Drug)
结局指标
主要结局
Change in Hepcidin Levels
时间窗: 30 days
Comparison of Hepcidin Levels prior to and after Nelfinavir treatment
次要结局
- Change From Baseline in Serum Fibrosis Biomarker Concentrations(30 days)
- Change in Hemoglobin Levels(30 days)
- Change in Fibrosis Biomarkers(30 days)
研究者
Angela G. Fleischman
Associate Professor
University of California, Irvine
研究点 (1)
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