EUCTR2020-004553-72-DE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)
oxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company0 个研究点目标入组 500 人开始时间: 2021年3月9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
- •Measurable disease by PET-CT and/or CT/MRI as defined by Lugano
- •criteria and aligned with protocol imaging requirements:
- •- at least one nodal lesion (> 1.5 cm in long axis) or extranodal
- •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.
- •Eastern Cooperative Oncology Group (ECOG) performance status 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 central nervous system (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 during Screening.
- •Known human immunodeficiency virus (HIV) infection, regardless of
- •Known active hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •Known active cytomegalovirus (CMV) infection. Unknown or negative
- •status are eligible.
- •Pregnancy during the study or within 3
- •months of the last dose of study treatment.
- •Clinically significant active malabsorption syndrome or other condition
- •likely to affect 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, non-melanoma skin cancer curatively treated, nonmetastatic
- •breast, or nonmetastatic prostate cancer where hormonal therapy is
- •being continued as standard of care are allowed.
- •Prior/Concomitant Therapy
- •Ongoing chronic treatment with strong cytochrome P450 3A4
- •(CYP3A4) inhibitors or inducers which cannot be stopped within 3-5
- •half-lives of the CYP3A inhibitor therapy prior to start of study drug
- •Because of their effect on CYP3A4, use of any of the following within 3
- •days of study therapy start is prohibited: Grapefruit or grapefruit
- •products, Seville oranges or products from Seville oranges, Star fruit or
- •star fruit products.
- •Steroid use with antineoplastic intent within 7 days of study drug
- •initiation.
- •Patients requiring therapeutic anticoagulation with warfarin or another
- •vitamin K antagonist.
- •Vaccination with a live vaccine within 28 days prior to randomization.
- •Have a known hypersensitivity to any of the excipients of pirtobrutinib
- •or to the intended covalent BTK inhibitor if randomized to control arm.
- •Laction, or plan to breastfeed during the study or within 2 weeks of the
- •last dose of study treatment
研究者
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