EUCTR2013-003561-34-GB进行中（未招募）1 期
A Multicenter, Open-Label, Phase 2 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects with Relapsed/Refractory Marginal Zone Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
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
入选标准
- •Subjects must meet all of the following criteria in order to be eligible:
- •1)Histologically documented marginal zone lymphoma including splenic, nodal, and extranodal sub-types, subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criteria 5
- •2)Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least partial remission (PR) or documented disease progression after, the most recent systemic treatment regimen
- •3)Men and women =18 years of age
- •4)Eastern Cooperative Oncology Group (ECOG) performance status of =2
- •5)=1 measurable lesion site on computed tomography (CT) scan (>1.5 cm in longest dimension). Lesions in anatomical locations (such as extremities or soft tissue lesions) that are not well visualized by CT may be measured by magnetic resonance imaging (MRI) instead. instead.(Subjects with spleen-only disease are considered as not having measurable disease.)
- •6)Life expectancy of >3 months, in the opinion of the investigator
- •7)Female subjects who are of non-reproductive potential (ie, post-menopausal by history - no menses for =2 years; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry.
- •8)Male and female subjects who agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days (females) and 90 days (males) after the last dose of study drug
- •9)Documented evidence of need for treatment, including, but not limited to, threatened end-organ function, bulky disease (>5 cm), symptoms, requirement for transfusion or growth factor support, or medically significant need for intervention
- •10)For subjects with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase (LDH), rapidly worsening disease, or frequent B-symptoms, a pre-treatment biopsy is required to rule out large cell transformation
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Subjects who meet any of the following criteria are not eligible:
- •1)Medically apparent central nervous system lymphoma or leptomeningeal disease
- •2)History of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for =2 years
- •3)History of allogeneic stem-cell (or other organ) transplantation
- •4)Any chemotherapy, anticancer antibodies, or other systemic anticancer therapy within 21 days of the first dose of study drug
- •5)Any external beam radiation therapy within 6 weeks prior to the first dose of study drug
- •6)Use of radio- or toxin-immunoconjugates within 70 days of the first dose of study drug
- •7)Concurrent use of warfarin or other vitamin K antagonists
- •8)Concurrent use of a strong cytochrome P450 (CYP) 3A inhibitor. Subjects who have received a strong CYP3 A inhibitor prior to entering the study must have discontinued therapy for at least 5 half lives of the prohibited medication
- •9)Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration of >20 mg/day of prednisone) within 28 days of the first dose of study drug
- •10)Significant screening electrocardiogram (ECG) abnormalities including, but not limited to, left bundle branch block, 2nd degree atrioventricular (AV) block type II, 3rd degree block, or corrected QT interval (QTc) =470 msec. Subjects with a cardiac pacemaker who have a QTc interval of =470 msec may be eligible if these findings are
- •considered not clinically significant as documented via a cardiology
- •evaluation.
- •11)Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (New York Heart Association >Class 2), unstable angina, uncontrolled hypertension, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- •12)Recent infection requiring intravenous anti-infective treatment that was completed =14 days before the first dose of study drug
- •13)Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4.03), Grade 0 or 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
- •14)Known bleeding diathesis (eg, von Willebrand’s disease) or hemophilia
- •15)Known history of infection with human immunodeficiency virus (HIV) or history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV), or any uncontrolled active systemic infection
- •16)Any of the following abnormalities:
- •- Absolute neutrophil count (ANC) <750 cells/mm3 (0.75 x 109/L), unless there is documented bone marrow involvement
- •- Platelet count <50,000 cells/mm3 (50 x 109/L) independent of transfusion support, unless there is documented bone marrow involvement
- •- Serum aspartate transaminase (AST) or alanine transaminase (ALT) =3.0 x upper limit of normal (ULN)
- •- Creatinine >2.0 x ULN or Estimated Glomerular Filtration Rate (G
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