A Study to Evaluate LOXO-305 Vs. Approved BTK Inhibitor Approved Drugs to Treat Patients with Mantle Cell Lymphoma

Overview

About this study

The purpose of this study is to compare progression-free survival (PFS) of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Confirmed Mantle Cell Lymphoma (MCL) diagnosis.
  • Previously treated with at least one prior line of systemic therapy for MCL.
  • Measurable disease per Lugano criteria.
  • Eastern Cooperative Oncology Group (ECOG) 0-2.
  • Absolute neutrophil count ≥ 0.75 × 10^9/L without granulocyte-colony stimulating factor support within 7 days of screening.
  • Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening.
  • Platelets ≥ 50 × 10^9/L not requiring transfusion support or growth factors within 7 days of screening.
  • AST and ALT ≤ 3.0 x upper limit of normal (ULN).
  • Total bilirubin ≤ 1.5 x ULN.
  • Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula.

Exclusion Criteria:

  • Prior treatment with an approved or investigational BTK inhibitor.
  • History of bleeding diathesis.
  • History of stroke or intracranial hemorrhage within 6 months of randomization.
  • History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization.
  • Clinically significant cardiovascular disease.
  • Prolonged QT interval corrected using Fridericia's formula (QTcF) > 470 ms on 2/3 consecutive ECGs, and mean QTcF > 470 ms on all 3 ECGs.
  • Known HIV infection or active HBV, HCV, or CMV infections.
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption.
  • Current treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong P-gp inhibitors.
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
  • Vaccination with live vaccine within 28 days prior to randomization.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yucai Wang, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Han Tun, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20517038

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