A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator's Choice of Idelalisib plus Rituximab or Bendamustine plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma - BRUIN CLL-321

Shahda , MD Safi0 个研究点目标入组 10 人开始时间: 2021年8月24日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria
•- Previously treated with a covalent BTK inhibitor
•- Eastern Cooperative Oncology Group (ECOG) 0-2
•- Absolute neutrophil count => 0.75 * 109/L without granulocyte-colony stimulating factor support
•- Hemoglobin => 8 g/dL not requiring transfusion support or growth factors within 14 days of Cycle 1 Day 1
•- Platelets => 50 * 109/L not requiring transfusion support or growth factors within 14 days of C1D1. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be => (75 * 109/L).
•- AST and ALT <= 3.0 * upper limit of normal (ULN).
•- Total bilirubin <= 1.5 * ULN.
•- Estimated creatinine clearance of => 40 mL/min.

•- Known or suspected Richter's transformation at any time preceding enrollment.
•- Known or suspected history of central nervous system (CNS) involvement by CLL/SLL
•- Ongoing drug-induced liver injury
•- Active uncontrolled auto-immune cytopenia
•- Significant cardiovascular disease
•- History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days
•- Active hepatitis B or hepatitis C
•- Known active cytomegalovirus (CMV) infection.
•- Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
•- Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count.
•- Clinically significant active malabsorption syndrome or inflammatory bowel disease
•- Prior exposure to non-covalent (reversible) BTK inhibitor.
•- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
•- Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers and/or strong P-glycoprotein (P-gp) inhibitors
•- Vaccination with a live vaccine within 28 days prior to randomization
•- Patients with the following hypersensitivity:
•1) Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305, idelalisib, and bendamustine
•2) Prior significant hypersensitivity to rituximab

发起方

Shahda , MD Safi