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)

Running, not enrolling · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

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.

Key facts

Study ID

NCT04666038

Run by

Loxo Oncology, Inc.

People needed

238

Starts

2021-03-09

Expected to finish

2027-05-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• 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.
• Prior significant hypersensitivity to rituximab.

Where it is running

• Mitchell Cancer Institute -University of South Alabama — Mobile, Alabama, United States
• Palo Verde Hematology Oncology — Glendale, Arizona, United States
• Arizona Oncology Associates, P.C. - HOPE — Tucson, Arizona, United States
• Orange Coast Memorial Medical Center — Fountain Valley, California, United States
• California Research Institute — Los Angeles, California, United States
• Rocky Mountain Cancer Center — Aurora, Colorado, United States
• Medical Oncology Hematology Consultants, PA — Newark, Delaware, United States
• Boca Raton Regional Hospital — Boca Raton, Florida, United States
• Cancer Specialists of North Florida -St Augustine — Jacksonville, Florida, United States
• Oncology-Hematology Associates of West Broward — Tamarac, Florida, United States
• WellStar Health System — Marietta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Illinois Cancer Specialists-Niles — Niles, Illinois, United States
• Community Health Network — Indianapolis, Indiana, United States
• Arnett Cancer Center — Lafayette, Indiana, United States
• University of Kentucky Markey Cancer Center — Lexington, Kentucky, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Mercy Health-Paducah Medical Oncology and Hematology — Paducah, Kentucky, United States
• Cancer Center Office of Clinical Research — New Orleans, Louisiana, United States
• Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
• Saint Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• Ascension St. John Hospital — Grosse Pointe Woods, Michigan, United States
• Minnesota Oncology/Hematology PA — Saint Paul, Minnesota, United States
• St. Vincent Frontier Cancer Center — Billings, Montana, United States
• Southern Cancer Center, P.C. — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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