EUCTR2020-004553-72-IT进行中（未招募）1 期
A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator Choice of BTK Inhibitor in Patients with Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321) - na
OXO ONCOLOGY INCORPORATED0 个研究点目标入组 500 人开始时间: 2021年6月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •At least 18 years of age
- •Confirmed diagnosis by local laboratory of MCL with documentation of overexpression of cyclin D1 with at least one B-cell marker (e.g., CD19, CD20, or PAX5) and/or t (11;14), by cytogenetics, fluorescent in situ
- •hybridization (FISH) or polymerase chain reaction.
- •Previously treated with at least one prior line of systemic therapy for MCL.
- •Measurable disease on radiologic assessment as defined by Lugano criteria: at least one nodal lesion (> 1.5 cm in long axis) or extra-nodal lesion (> 1.0 cm in long axis) measurable in 2 dimensions, not
- •previously radiated (unless progression has been radiographically documented following radiation therapy).
- •Documented evidence of radiographically and/or histologically confirmed PD on the most recent line of therapy or relapse prior to study enrollment.
- •ECOG 0-2.
- •Adequate organ function
- •Must have life expectancy of at least 3 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •Current suspected or confirmed active CNS involvement with MCL or previous CNS involvement.
- •Prior treatment with an approved or investigational BTK inhibitor.
- •Major surgery within 4 weeks prior to randomization.
- •History of bleeding diathesis.
- •History of stroke or intracranial hemorrhage within 6 months of randomization.
- •History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within 60 days of randomization.
- •Significant cardiovascular disease.
- •Prolongation of the QT interval corrected for heart rate (QTcF) > 470 msec on at least 2/3 consecutive electrocardiograms (ECGs), and mean QTcF > 470 msec on all 3 ECGs, during Screening.
- •Known human immunodeficiency virus (HIV) infection, regardless of CD4 count.
- •Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible.
- •Pregnancy, lactation or plan to breastfeed during the study or within 30 days of the last dose of study treatment.
- •Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.
- •Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically
- •significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for patient participation. Screening for chronic conditions is not required.
- •History of second malignancy unless in remission for at least 2 years; in-situ carcinomas not requiring treatment intervention and nonmetastatic breast or prostate cancer where hormonal therapy is being
- •continued as standard of care are allowed.
- •Prior/Concomitant Therapy
- •Current treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong P-gp inhibitors. Because of their effect on CYP3A4, use of any of the following within 3 days of study therapy start or planned use during study participation is prohibited: grapefruit or grapefruit products, Seville oranges or products from Seville oranges, star fruit.
- •Steroid use with anti-neoplastic intent within 7 days of study drug initiation.
- •Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.
- •Vaccination with live vaccine within 28 days prior to randomization.
- •Have a known hypersensitivity to any of the excipients of LOXO-305 or to the intended covalent BTK inhibitor if randomized to control arm.
研究者
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