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Clinical Trials in the UK / NCT04666038
Active, not recruiting Phase 3

Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

NCT04666038 · tracked via the Priya Life Science UK tracker
Sponsor
Loxo Oncology, Inc.
Phase
Phase 3
Started
2021-03-09
Last updated
2026-04-24

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

PirtobrutinibIdelalisibBendamustineRituximab

Pirtobrutinib: Oral Pirtobrutinib

Idelalisib: Oral

Bendamustine: IV

Rituximab: IV

Study summary

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 × 10\^9/L without granulocyte-colony-stimulating factor support, or ≥ 0.50 × 10\^9/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte-colony-stimulating factor support is permitted in patients with documented bone marrow involvement. * Hemoglobin ≥ 8 g/dL or ≥ 6 g/dL in patients with documented bone marrow involvement considered to impair hematopoiesis. Transfusion support is permitted in patients with bone marrow involvement. * Platelets ≥ 50 × 10\^9/L. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ 75 × 10\^9/L. Patients may enroll below these thresholds if the Investigator determines the cytopenia is related to bone marrow involvement considered to impair hematopoiesis. Patients with a platelet count \< 30 x 10\^9/L are excluded. * 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. * 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. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine. 2. Prior significant hypersensitivity to rituximab.

Primary outcome measure(s)

Trial sites (232)

FacilityCityRegionStatus
Southern Cancer Center, P.C. Daphne Alabama
Mitchell Cancer Institute -University of South Alabama Mobile Alabama
Palo Verde Hematology Oncology Glendale Arizona
Arizona Oncology Associates, P.C. - HOPE Tucson Arizona
Orange Coast Memorial Medical Center Fountain Valley California
California Research Institute Los Angeles California
Rocky Mountain Cancer Center Aurora Colorado
Medical Oncology Hematology Consultants, PA Newark Delaware
Boca Raton Regional Hospital Boca Raton Florida
Cancer Specialists of North Florida -St Augustine Jacksonville Florida
Oncology-Hematology Associates of West Broward Tamarac Florida
WellStar Health System Marietta Georgia
Rush University Medical Center Chicago Illinois
Illinois Cancer Specialists-Niles Niles Illinois
Community Health Network Indianapolis Indiana
Arnett Cancer Center Lafayette Indiana
University of Kentucky Markey Cancer Center Lexington Kentucky
Norton Cancer Institute Louisville Kentucky
Mercy Health-Paducah Medical Oncology and Hematology Paducah Kentucky
Cancer Center Office of Clinical Research New Orleans Louisiana
Greenebaum Comprehensive Cancer Center Baltimore Maryland
Saint Joseph Mercy Hospital Ann Arbor Michigan
Ascension St. John Hospital Grosse Pointe Woods Michigan
Minnesota Oncology/Hematology PA Saint Paul Minnesota
St. Vincent Frontier Cancer Center Billings Montana
Nebraska Hematology-Oncology Lincoln Nebraska
New Jersey Center for Cancer Research Brick New Jersey
Memorial Sloan Kettering Cancer Center New York New York
University of Rochester Rochester New York
Clinical Research Alliance, Inc. Westbury New York
Oncology Hematology Care Inc Cincinnati Ohio
Willamette Valley Cancer Institute and Research Center Eugene Oregon
Carolina Blood and Cancer Care Associates Rock Hill South Carolina
Texas Oncology - Amarillo Amarillo Texas
Texas Oncology Cancer Center Austin Texas
Texas Oncology - Medical City Dallas Dallas Texas
Texas Oncology - Dallas Presbyterian Hospital Dallas Texas
Brooke Army Medical Center Fort Sam Houston Texas
Texas Oncology Fort Worth Fort Worth Texas
The Center for Cancer and Blood Disorders Fort Worth Texas

+ 192 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile →

More Loxo Oncology, Inc. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04666038 on ClinicalTrials.gov ↗ ← All trials in the UK