Study Comparing BTK Inhibitor LOXO-305 to Other Approved BTK Inhibitor Drugs in Patients with Mantle Cell Lymphoma

Sponsor: Loxo Oncology, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04662255

Provider View

This clinical trial is for patients with mantle cell lymphoma (MCL), a type of blood cancer. The study aims to compare a new drug, pirtobrutinib (LOXO-305), with other similar drugs that are already approved. Participants may be involved in the study for up to two years or longer if their disease does not worsen.

Patient Parameters

Program Overview

The study is designed to compare the effectiveness of a new drug called pirtobrutinib (LOXO-305) with other approved drugs for treating mantle cell lymphoma (MCL). Participants will be randomly assigned to receive either pirtobrutinib or one of the other approved drugs, such as ibrutinib, acalabrutinib, or zanubrutinib. The study is open to patients who have already received at least one treatment for MCL and have not been treated with BTK inhibitors before.

Description

This is a Phase 3 study, which means it is in the later stages of testing. It is being conducted globally and involves randomly assigning participants to one of two groups. One group will receive the new drug pirtobrutinib, while the other group will receive one of the approved BTK inhibitor drugs chosen by the study doctor. The study is open-label, meaning both the participants and the researchers know which treatment is being given. The goal is to see how well pirtobrutinib works compared to the other drugs in patients with mantle cell lymphoma who have already tried other treatments.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of mantle cell lymphoma (MCL).
  • Have been treated with at least one previous therapy for MCL.
  • Have measurable disease according to specific medical criteria.
  • Be in good overall health with an ECOG performance status of 0 to 2, meaning fully active or able to carry out light work.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 0.75 × 10^9/L without needing growth factors.
    • Hemoglobin level of at least 8 g/dL without needing transfusions or growth factors.
    • Platelet count of at least 50 × 10^9/L without needing transfusions or growth factors.
    • Liver enzymes (AST and ALT) within 3 times the normal limit.
    • Total bilirubin within 1.5 times the normal limit.
    • Kidney function with creatinine clearance of at least 30 mL/min.

Exclusion Criteria

  • Have previously been treated with any BTK inhibitor drugs.
  • Have a history of bleeding disorders.
  • Have had a stroke or brain bleeding within the last 6 months.
  • Have had a stem cell transplant or CAR-T therapy within the last 60 days.
  • Have significant heart disease.
  • Have a prolonged QT interval on an ECG test.
  • Have active infections like HIV, hepatitis B, C, or CMV (some controlled hepatitis B cases may be allowed).
  • Have a condition that affects the absorption of medications in the stomach or intestines.
  • Are taking certain medications that affect how the body processes drugs and cannot stop them before starting the study.
  • Are taking blood thinners like warfarin.
  • Have received a live vaccine within the last 28 days.

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