BENITIONSClinical Trial Intelligence

Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

3期 进行中(已停止招募) NCT02048813

适应症Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
分期3期
申办方National Cancer Institute (NCI)
状态进行中(已停止招募)
受试者人数529 人
干预(药物)Cyclophosphamide, Fludarabine Phosphate, Ibrutinib, Laboratory Biomarker Analysis, Pharmacogenomic Study
开始日期2014年3月10日
完成日期2018年10月24日
结果公布日2023年8月14日

摘要

This phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Progression-free Survival (PFS) Rate at 3 Years

Assessed every 3 months until progression up to 4 years and 8 months · Proportion of participants

Arm A (Ibrutinib, Rituximab)0.894 Proportion of participants
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)0.729 Proportion of participants
p-value<.001
Hazard Ratio (HR)0.35 (95% CI 0.22–0.56)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。