ACTRN12621001361897尚未招募2 期
A single arm, open-label study of efficacy and safety of the Exportin 1 inhibitor selinexor in relapsed/refractory CNS Lymphoma and in relapsed/refractory CNS Myeloma
Australasian Myeloma Research Consortium0 个研究点目标入组 20 人开始时间: 2021年10月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Age 18 years old or older
- •2.Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
- •3.Eastern Cooperative Oncology Group (ECOG) equal to or less than 2
- •4.Patients with relapsed/refractory CNS lymphoma according to the current World Health Organization classification, having had 1 line of induction treatment or more with no clinically-appropriate viable alternative options available. Patients with synchronous systemic involvement may be eligible after discussion with the CPI.
- •5.Patients with CNS multiple myeloma according to the current World Health Organization classification, with no clinically-appropriate alternative treatment available. Patients with systemic involvement are eligible.
- •6.Patients should have measurable CNS disease on imaging/scans, or leptomeningeal disease evident on CSF analysis via lumbar punctures.
- •7.Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
- •8.Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
- •9.Adequate hepatic function within 28 days prior to C1D1:
- •a.total bilirubin equal to or less than 1.5 × upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of equal to or less than 3 × ULN), and
- •b.aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal to equal to or less than 2 × ULN.
- •10.Adequate renal function within 28 days prior to C1D1 as determined by serum creatinine of equal to or less than 132 µmol/L OR estimated creatinine clearance of equal to or greater than 30 mL/min, calculated using the Cockcroft and Gault formula (140 – Age) • Mass (kg)/ (72 • creatinine mg/dL); multiply by 0.85 if female (Cockcroft 1976).
- •11.Adequate hematopoietic function within 7 days prior to C1D1:
- •a.total white blood cell (WBC) count equal to or greater than 1.5 x 10^9/L ,
- •b.absolute neutrophil count equal to or greater than 1.0 x 10^9/L
- •c.hemoglobin equal to or greater than 85 g/L and
- •d.platelet count equal to or greater than 75 x 10^9/L (patients for whom <50% of bone marrow nucleated cells are plasma cells) or equal to or greater than 50 10^9/L (patients for whom equal to or greater than 50% of bone marrow nucleated cells are plasma cells).
- •12.Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (eg, eltrombopag, romiplostim, or interleukin-11) must have a 2-week interval between growth factor support and the Screening assessments, but they may receive growth factor support during the study.
- •13.Patients must have at least a 2-week interval from the last red blood cell (RBC) and/or platelet transfusion prior to the Screening hemoglobin assessment (Patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study.)
- •14.Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing pot
排除标准
- •1.Has received selinexor or another XPO1 inhibitor previously.
- •2.Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 5 years prior to randomization. Cancer treated with curative intent for >5 years previously and without evidence of recurrence will be allowed.
- •3.Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
- •4.Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
- •5.Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
- •6.Pregnant or breastfeeding females.
- •7.Life expectancy of less than 12 weeks.
- •8.Major surgery within 4 weeks prior to C1D1.
- •9.Active, unstable cardiovascular function, as indicated by the presence of:
- •a)Symptomatic ischemia, or
- •b)Uncontrolled clinically significant conduction abnormalities (eg, patients with ventricular tachycardia on anti-arrhythmics are excluded; patients with first degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block will not be excluded), or
- •c)Congestive heart failure of New York Heart Association Class equal to or greater than 3 or known left ventricular ejection fraction less than 40%, or
- •d)Myocardial infarction within 3 months prior to C1D1.
- •10.Known active human immunodeficiency virus (HIV) infection or HIV seropositivity.
- •11.Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus ribonucleic acid (RNA) or hepatitis B virus surface antigen.
- •12.Any active gastrointestinal dysfunction interfering with the patient’s ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
- •13.Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (CPGO) (NCCN CPGO) for antiemesis and anorexia/cachexia (palliative care).
- •14.Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
- •15.Contraindication to any of the required concomitant drugs or supportive treatments.
- •16.Patients unwilling or unable to comply with the protocol requirements
- •17.Previous hypersensitivity to selective inhibitor of nuclear export (SINE) drugs.
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