EUCTR2016-002980-33-GB进行中（未招募）1 期
A Phase 3, Randomized, Open-Label, Multicenter StudyComparing the Efficacy and Safety of the Bruton’s TyrosineKinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjectswith Waldenström’s Macroglobulinemia (WM)
BeiGene Ltd. c/o BeiGene USA Inc.0 个研究点目标入组 210 人开始时间: 2017年6月2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
- 210
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
- •1. Clinical and definitive histologic diagnosis of WM.Subjects must either have relapsed/refractory disease OR be treatment naïve and considered by their treating physician to be unsuitable for standard
- •chemoimmunotherapy regimens.
- •a. For subjects who have received no prior therapy for WM: Unsuitable for treatment with a standard chemoimmunotherapy regimen must be a physician-determined status based on co-morbidities and risk factors. Physicians will need to provide and document organ system(s) and specific reason(s) for subject being considered unsuitable. Patient preference does not meet the eligibility requirement for a
- •treatmentnaïve subject to be unsuitable for treatment with a standard chemoimmunotherapy regimen.
- •2. Meeting at least one criterion for treatment according to consensus panel criteria from the Seventh IWWM (Dimopoulos et al 2014)
- •3. Measurable disease, as defined by serum IgM level >0.5 g/dL
- •4. Age = 18 years old
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •6. Adequate bone marrow function defined as:
- •- Neutrophils = 0.75 x 10 power 9/L independent of growth factor support within 7 days of study entry
- •- Platelets = 50 x 10 power 9/L, independent of growth factor support or transfusion within 7 days of study entry
- •7. Creatinine clearance of = 30 ml/min (as estimated by the CockcroftGault equation or estimated glomerular filtration rate [eGFR] from the Modification of Diet in Renal Disease [MDRD])based on ideal body mass.
- •11. Subjects who relapse after autologous stem cell transplant are eligible if they are at least 3 months after transplant, and are eligible after allogeneic transplant if they are at least 6 months post-transplant. To be eligible after either type of transplant, subjects should have no active infections or in the case of allogeneic transplant relapse, no active acute graft versus host disease (GvHD) of any grade, and no chronic
- •GvHD other than mild skin, oral, or ocular GvHD not requiring systemic immunosuppression.
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 145
排除标准
- •1. Prior exposure to a BTK inhibitor.
- •2. Evidence of disease transformation at the time of study entry.
- •3. Corticosteroids given with antineoplastic intent within 7 days, or chemotherapy, targeted therapy, or radiation therapy within 3 weeks, or antibody-based therapy within 4 weeks of the start of study drug.
- •4. Major surgery within 4 weeks of study treatment.
- •5. Ongoing toxicity of = Grade 2 from prior anticancer therapy (except for alopecia, absolute neutrophil count [ANC] and platelets). For ANC and platelets, please follow inclusion criteria #6 [neutrophils] and [platelets]).
- •6. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous
- •malignancy confined and treated locally (surgery or other modality) with curative intent.
- •7. Currently active, clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease (congestive heart failure) as defined by the New York
- •Heart Association (NYHA) Functional Classification, or history of myocardial infarction within 6 months of screening.
- •8. QTcF prolongation (defined as a QTcF > 480 msec)
- •9. Active, clinically significant Electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block Type II, or third degree AV block.
- •10. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease,
- •or partial or complete bowel obstruction.
- •11. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy that was completed =14 days before the first dose of study drug.
- •12. Known infection with human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B or hepatitis C as follows:
- •a) Presence of hepatitis B surface antigen (HbsAg) or anti-hepatitis core antibody (anti-HBc). Patients with presence of anti-HBc, but absence of HBsAg are eligible if hepatitis B virus (HBV) DNA is undetectable and if
- •they are willing to undergo monthly monitoring for HBV reactivationb).
- •b) Presence of hepatitis C virus (HCV] antibody. Patients with presence of HCV antibody are eligible if HCV ribonucleic acid (RNA) is undetectable.
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