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) (BRUIN CLL-321)

  • End date
    Jun 22, 2024
  • participants needed
  • sponsor
    Loxo Oncology, Inc.
Updated on 22 October 2022
chronic lymphocytic leukemia
neutrophil count
btk inhibitor


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.


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.

Condition Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Treatment Rituximab, Bendamustine, Idelalisib, LOXO-305
Clinical Study IdentifierNCT04666038
SponsorLoxo Oncology, Inc.
Last Modified on22 October 2022


Yes No Not Sure

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
Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305, idelalisib, and bendamustine
Prior significant hypersensitivity to rituximab
Clear my responses

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