EUCTR2019-001755-39-IT进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects <= 65 Years with Previously Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma. - ESCALADE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •- Men and women, age >=18 and <=65 years
- •- Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review.
- •- No prior treatment for DLBCL
- •- Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
- •- International Prognostic Index (IPI) score of 2 to 5
- •- Disease Stage II to IV by the Ann Arbor Classification
- •- Adequate organ and marrow function
- •- Agreement to use highly effective forms of contraception during the study and 12 months after the last dose of rituximab
- •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 570
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Evidence of severe or uncontrolled systemic diseases
- •- Known history of a bleeding diathesis (i.e., haemophilia, von Willebrand disease)
- •- History of stroke or intracranial haemorrhage in preceding 6 months.
- •- Known CNS lymphoma or leptomeningeal disease
- •- Known primary mediastinal lymphoma
- •- Known High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
- •- Prior history of indolent lymphoma
- •- History of or ongoing confirmed progressive multifocal leukoencephalopathy
- •- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- •- Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
- •- Uncontrolled active systemic fungal, bacterial, viral, or other infection
- •- Prior anthracycline use >=150 mg/m2
- •- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer.
- •- Requires treatment with proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Patients receiving proton pump inhibitors who switch to short-acting H2-receptor antagonists or antacids are eligible for enrolment into this study.
研究者
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