Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With CLL or SLL

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loxo Oncology, Inc.
• Treatments: Bendamustine Hydrochloride; Idelalisib; Rituximab

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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