RecruitingChronic Lymphocytic LeukemiaLeukemia, LymphocyticLeukemia, B-cell

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.

Sponsor: Loxo Oncology, Inc.

You may qualify if…

✓ Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
✓ Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
✓ Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
✓ Adequate organ function
✓ Platelets greater than or equal to ≥ 50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
✓ Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
✓ Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
✓ Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

You may not qualify if…

✕ Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
✕ Known or suspected central nervous system (CNS) involvement
✕ A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
✕ Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\])
✕ Significant cardiovascular disease including ejection fraction \< 40% and any grade ongoing atrial fibrillation or atrial flutter
✕ Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
✕ Active cytomegalovirus (CMV) infection
✕ Active uncontrolled systemic bacterial, viral, or fungal infection