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

clipboard-pencil

About the study

The purpose 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. Participation could last up to six years.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. * Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
  2. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  3. * Adequate organ function
  1. * 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,
  2. * Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
  3. * Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
  4. * Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

EXCLUSION CRITERIA

Exclusion Criteria:

  1. * Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
  2. * Known or suspected central nervous system (CNS) involvement
  3. * A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
  4. * Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\])
  5. * Significant cardiovascular disease including ejection fraction \< 40% and any grade ongoing atrial fibrillation or atrial flutter
  6. * Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
  7. * Active cytomegalovirus (CMV) infection
  8. * Active uncontrolled systemic bacterial, viral, or fungal infection
  9. * Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  10. * Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
  11. * Ongoing inflammatory bowel disease
  12. * Prior exposure to BTK inhibitor (covalent or noncovalent)
  13. * Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  14. * Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  15. * Use of ≥ 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
  16. * Vaccination with a live vaccine within 28 days prior to randomization
  17. * Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment
  18. * Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-317-615-4559Email iconEmail Study Center

Study Details


Contition
Chronic Lymphocytic Leukemia,Leukemia, Lymphocytic,Leukemia, B-cell,Small Lymphocytic Lymphoma
Age (in years)
18+
Phase
PHASE3
Participants Needed
650
Est. Completion Date
Aug 31, 2028
Treatment Type
INTERVENTIONAL

Sponsor
Eli Lilly and Company
ClinicalTrials.gov NCT Identifier
NCT05254743
Study Number
LOXO-BTK-20030

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?