EUCTR2013-005542-11-BG进行中（未招募）1 期
A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared with Rituximab in Subjects with CD20 Positive B-Cell Non-Hodgkin Lymphoma (NHL) - Not Applicable
Amgen Inc.0 个研究点目标入组 250 人开始时间: 2014年9月10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
- 250
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
- •Males and females 18 years of age and older
- •Histological confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, 3a follicular B-cell NHL expressing CD20 within 12 months before randomization
- •Stage 2, 3, or 4 (per Cotswold’s Modification of Ann Arbor Staging System) with measurable disease (per International Working Group)
- •subjects must have a baseline scan (computed tomography [CT]) of the neck (if palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease burden within 6 weeks before randomization
- •subjects must have had a baseline bone marrow biopsy within 12 months before randomization. Previously confirmed positive bone marrow involvment does not need to be repeated for purposes of screening.
- •Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria
- •- largest nodal or extranodal mass = 7 cm
- •- no more than 3 nodal sites with diameter > 3 cm
- •- no splenomegaly > 16 cm by CT scan and no symptomatic splenomegaly
- •- no significant pleural or peritoneal serous effusions by CT
- •- lactate dehydrogenase = upper limit of normal (ULN)
- •- no B symptoms (night sweats, fever [temperature > 38 C], weight loss > 10% in the previous 6 months)
- •5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
- •Blood counts:
- •absolute neutrophil count (ANC) = 1.5 x 109 /L (1,500/µL)
- •lymphocytes < 1.5 x the ULN
- •platelets = 100 x 109 /L (100,000/µL)
- •hemoglobin = 10.0 g/dL
- •Adequate hepatic function as defined by:
- •aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 × ULN
- •Adequate renal function as defined by creatinine < 1.5 x ULN or estimated creatinine clearance = 50 mL/min calculated by the Cockcroft-Gault method
- •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 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
排除标准
- •Diffuse large cell component and/or Grade 3 follicular NHL
- •History or known presence of central nervous system metastases
- •Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or squamous or basal cell carcinoma of the skin)
- •Any of the following in the 6 months before randomization:
- •clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association = Class III], serious uncontrolled cardiac arrhythmia); peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months
- •Medically uncontrolled hypertension or systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg
- •Known active or history of active tuberculosis (TB)
- •Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening
- •Known to be human immunodeficiency virus positive
- •Recent infection requiring a course of systemic anti-infective agents that was completed = 7 days before randomization (with the exception of uncomplicated urinary tract infection)
- •Other investigational procedures that can impact the study data, results, or patient safety while participating in the study are excluded; participation in observational studies is allowed.
- •Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives (whichever is longer) since ending other investigational device or drug study(s), including vaccines, or subject is receiving other investigational agent(s)
- •Previous use of either commercially available or investigational chemotherapy, biological, or immunological therapy for NHL (including rituximab or biosimilar rituximab, or other anti-CD20 treatments)
- •Systemic corticosteroid use within 3 months before randomization (inhaled are allowable)
- •Live vaccines within 28 days prior to the first dose of IP
- •History of neurologic symptoms suggestive of central nervous system demyelinating disease
- •Woman of childbearing potential who is pregnant or is breastfeeding
- •Woman of childbearing potential who does not consent to use highly effective methods of birth control (eg, true abstinence, sterilization, birth control pills, Depo Provera injections, or contraceptive implants) during treatment and for an additional 12 months after the last administration of the protocol specified-treatment
- •Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control (eg, true abstinence, vasectomy, or a condom in combination with hormonal birth control or barrier methods used by the woman) during treatment and for an additional 12 months after the last administration of the protocol specified treatment
- •Subject has known sensitivity to any of the products to be
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