Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

Running, not enrolling · Phase 3

Conditions studied: Lymphoma, Mantle-Cell

In brief

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

Key facts

Study ID

NCT04662255

Run by

Loxo Oncology, Inc.

People needed

500

Starts

2021-04-08

Expected to finish

2028-04-01

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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. (Certain participants with controlled HBV infections may still be eligible)
• 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 antagonist.
• Vaccination with live vaccine within 28 days prior to randomization

Where it is running

• Arizona Oncology Associates, P.C. - HOPE — Phoenix, Arizona, United States
• UCLA Medical Center — Los Angeles, California, United States
• USO-Rocky Mountain Cancer Center — Denver, Colorado, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Oncology-Hematology Associates of West Broward — Tamarac, Florida, United States
• Florida Cancer Specialists East — West Palm Beach, Florida, United States
• University of Kentucky Markey Cancer Center — Lexington, Kentucky, United States
• Mercy Health-Paducah Medical Oncology and Hematology — Paducah, Kentucky, United States
• Tulane Cancer Center Office of Clinical Research — New Orleans, Louisiana, United States
• Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
• DFCI Lymphoma — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University Medical School — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Messino Cancer Center — Asheville, North Carolina, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• Oncology Hematology Care Inc — Cincinnati, Ohio, United States
• Willamette Valley Cancer Institute & Research Ctr. — Eugene, Oregon, United States
• Sarah Cannon Research Institute SCRI — Nashville, Tennessee, United States
• Texas Oncology-Austin Midtown — Austin, Texas, United States
• Texas Oncology - Bedford — Bedford, Texas, United States
• Alaska Oncology and Hematology, LLC — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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