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


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 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 × 109/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 × 109/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

- Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or
inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy
prior to start of study drug treatment.

- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K

- Vaccination with live vaccine within 28 days prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/29/22. Questions regarding updates should be directed to the study team contact.

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


Jacksonville, Fla.

Mayo Clinic principal investigator

Han Tun, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions