EUCTR2013-005478-22-IT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects with Previously Treated Waldenstrom’s Macroglobulinemia
Pharmacyclics, Incorporated0 个研究点目标入组 181 人开始时间: 2014年4月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 181
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
- •For the Randomized Study (Arm A and Arm B):
- •- Previously treated for Waldenstrom’s macroglobulinemia and have either documented disease progression or had no response (stable disease) to the most recent treatment regimen.
- •- Centrally confirmed clinicopathological diagnosis of WM in accordance with the consensus panel of the Second International Workshop on WM (Owen 2003).
- •- Measurable disease defined as serum monoclonal IgM >0.5 g/dL.
- •- Symptomatic disease meeting at least 1 of the recommendations from the Second International Workshop on Waldenström Macroglobulinemia for requiring treatment (Kyle 2003).
- •- Adequate hematologic function.
- •- Adequate hepatic and renal function.
- •- PT/INR =1.5 x ULN and PTT (aPTT) =1.5 x ULN.
- •- Eastern Cooperative Oncology Group (ECOG) performance status of =2. Ethical/Other
- •For the Open-label Substudy Treatment Arm C:
- •To be enrolled in the substudy, each potential subject must meet all of the inclusion criteria defined in Protocol Section 4.1.1 (Arm A & Arm B). IN ADDITION, the following criterion must be met:
- •1. Disease that is refractory to the last prior rituximab-containing therapy defined as either
- •Relapse after the last rituximab-containing therapy <12 months since last dose of rituximab,
- •Failure to achieve at least a MR after the last rituximab-containing therapy.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •- Known involvement of the central nervous system by WM.
- •- Disease that is refractory to the last prior rituximab-containing therapy defined as either
- •Relapse after the last rituximab-containing therapy <12 months since last dose of
- •Failure to achieve at least a MR after the last rituximab-containing therapy.
- •If the subject meets this exclusion criterion and therefore is excluded from the main randomized study, participation in the non randomized substudy (Arm C) may be considered (Section 4.2)
- •- Rituximab treatment within the last 12 months before the first dose of study drug.
- •- Known anaphylaxis or IgE-mediated hypersensitivity to murine proteins or to any component of rituximab.
- •- Prior exposure to ibrutinib or other BTK inhibitors.
- •- Received any WM-related therapy (eg, chemotherapy, immunotherapy, investigational drug) =30 days prior to first administration of study treatment.
- •- Known bleeding disorders (eg, von Willebrand’s disease) or hemophilia.
- •- History of stroke or intracranial hemorrhage within 12 months prior to enrollment.
- •- Known history of infection with human immunodeficiency virus (HIV).
- •- History of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) .
- •- Any uncontrolled active systemic infection.
- •- Major surgery (as defined in Section 6.2.2) within 4 weeks of first dose of study drug.
- •- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk.
- •- Significant screening electrocardiogram (ECG) abnormalities.
- •- Currently active, clinically significant cardiovascular disease.
- •- Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function.
- •- Concomitant use of warfarin or other Vitamin K antagonists.
- •- Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
- •The exclusion criteria for the substudy are identical to those of the main randomized study as described in Protocol Section 4.1.2, EXCEPT for criteria 2, 3, and 4, which are related to prior rituximab use and do not apply for the substudy Arm C.
研究者
相似试验
进行中（未招募）
1 期
A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitisMedDRA version: 20.0 Level: PT Classification code 10072579 Term: Granulomatosis with polyangiitis System Organ Class: 10047065 - Vascular disordersMedDRA version: 20.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disordersMedDRA version: 20.1 Level: PT Classification code 10050894 Term: Anti-neutrophil cytoplasmic antibody positive vasculitis System Organ Class: 10021428 - Immune system disordersEUCTR2016-001121-14-CZChemoCentryx, Inc.300
进行中（未招募）
1 期
A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus ErythematosusMedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersSystemic Lupus ErythematosusEUCTR2019-003323-38-HUEli Lilly & Company280
进行中（未招募）
1 期
A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus ErythematosusMedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersSystemic Lupus ErythematosusEUCTR2019-003323-38-PLEli Lilly & Company280
进行中（未招募）
不适用
A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.Rheumatoid Arthritis (RA)MedDRA version: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2013-003984-72-ESAbbVie Inc.270
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidonePatients with Idiopathic Pulmonary Fibrosis (IPF)MedDRA version: 17.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2012-000564-14-GBInterMune International AG.122