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)

STATUS

Recruiting
End date

Jun 22, 2024
participants needed

250
sponsor

Loxo Oncology, Inc.

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Updated on 22 October 2022

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chronic lymphocytic leukemia

lymphoma

rituximab

neutrophil count

idelalisib

bendamustine

btk inhibitor

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.

Description

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.

Details

Condition	Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Treatment	Rituximab, Bendamustine, Idelalisib, LOXO-305
Clinical Study Identifier	NCT04666038
Sponsor	Loxo Oncology, Inc.
Last Modified on	22 October 2022

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Eligibility		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

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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)