Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With CLL or SLL
This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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 x upper limit of normal (ULN). - Total bilirubin ≤ 1.5 x ULN. - Estimated creatinine clearance of ≥ 30 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
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Eligible patients will be randomized in 1:1 into Arm A or Arm B. Patients randomized to Arm B who have disease progression (PD) confirmed by independent review committee (IRC) may be eligible to crossover into Arm A.
- Primary Purpose
- None (Open Label)
Arm A (LOXO-305)
Arm B (Idelalisib plus rituximab [IdelaR] or bendamustine plus rituximab [BR])
|Investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR).||
- Loxo Oncology, Inc.
Study ContactPatient Advocacy
This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm B) in CLL/SLL patients who have been treated with at least a covalent BTK inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression (PD) or intolerance. Patients who have received venetoclax are eligible for the study. Eligible patients will be randomized in 1:1 to Arm A and Arm B.