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

第3相 実施中(募集終了) NCT02048813

対象疾患Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
第3相
スポンサーNational Cancer Institute (NCI)
ステータス実施中(募集終了)
参加者数529 名
介入(薬剤)Cyclophosphamide, Fludarabine Phosphate, Ibrutinib, Laboratory Biomarker Analysis, Pharmacogenomic Study
開始日2014年3月10日
完了日2018年10月24日
結果公開日2023年8月14日

概要

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)

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