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Closed (no longer recruiting)Last updated: 11 June 2024

BRUIN-CLL-314: This study is comparing the safety and effectiveness of two targeted therapies in people with chronic lymphocytic leukaemia/small lymphocytic lymphomaA Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms. 

In Arm A (Experimental), participants will receive oral pirtobrutinib targeted therapy (also known as LOXO-305).

In Arm B (Active Comparator), participants will receive oral ibrutinib targeted therapy.

Conditions

This trial is treating patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

BRUIN-CLL-314

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Loxo Oncology, Inc.

Scientific Title

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Eligibility

Inclusion

  • Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
  • 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)

Exclusion

  • 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
  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  • Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
  • Ongoing inflammatory bowel disease
  • Prior exposure to BTK inhibitor (covalent or noncovalent)
  • Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  • Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  • Use of ≥ 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
  • Vaccination with a live vaccine within 28 days prior to randomization
  • 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
  • Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib

Inclusion

  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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