🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT04662255
Active, not recruiting Phase 3

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

NCT04662255 · tracked via the Priya Life Science UK tracker
Sponsor
Loxo Oncology, Inc.
Phase
Phase 3
Started
2021-04-08
Last updated
2026-05-15

Condition(s) studied

Lymphoma, Mantle-Cell

Investigational drug(s) / intervention(s)

PirtobrutinibIbrutinibAcalabrutinibZanubrutinib

Pirtobrutinib: Oral

Ibrutinib: Oral

Acalabrutinib: Oral

Zanubrutinib: Oral

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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. (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

Primary outcome measure(s)

Trial sites (189)

FacilityCityRegionStatus
Alaska Oncology and Hematology, LLC Anchorage Alaska
Arizona Oncology Associates, P.C. - HOPE Phoenix Arizona
UCLA Medical Center Los Angeles California
USO-Rocky Mountain Cancer Center Denver Colorado
Mayo Clinic in Florida Jacksonville Florida
Oncology-Hematology Associates of West Broward Tamarac Florida
Florida Cancer Specialists East West Palm Beach Florida
University of Kentucky Markey Cancer Center Lexington Kentucky
Mercy Health-Paducah Medical Oncology and Hematology Paducah Kentucky
Tulane Cancer Center Office of Clinical Research New Orleans Louisiana
Greenebaum Comprehensive Cancer Center Baltimore Maryland
DFCI Lymphoma Boston Massachusetts
Karmanos Cancer Institute Detroit Michigan
Mayo Clinic Rochester Minnesota
Washington University Medical School St Louis Missouri
Columbia University Medical Center New York New York
Memorial Sloan Kettering Cancer Center New York New York
Messino Cancer Center Asheville North Carolina
Levine Cancer Institute Charlotte North Carolina
Wake Forest University School of Medicine Winston-Salem North Carolina
Oncology Hematology Care Inc Cincinnati Ohio
Willamette Valley Cancer Institute & Research Ctr. Eugene Oregon
Sarah Cannon Research Institute SCRI Nashville Tennessee
Texas Oncology-Austin Midtown Austin Texas
Texas Oncology - Bedford Bedford Texas
University of Texas MD Anderson Cancer Center Houston Texas
Texas Oncology - McAllen McAllen Texas
Texas Oncology - Sherman Sherman Texas
US Oncology The Woodlands Texas
Texas Oncology - Tyler Tyler Texas
Huntsman Cancer Institute Salt Lake City Utah
University of Virginia Health System Charlottesville Virginia
USO-Virginia Cancer Specialists, PC Fairfax Virginia
Seattle Cancer Care Alliance Seattle Washington
University of Wisconsin Carbone Cancer Center Madison Wisconsin
Froedtert Memorial Lutheran Hospital Milwaukee Wisconsin
The St. George Hospital Kogarah New South Wales
Royal Hobart Hospital Hobart Tasmania
Linear Clinical Research Nedlands Western Australia
Royal Perth Hospital Perth Western Australia

+ 149 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04662255 on ClinicalTrials.gov ↗ ← All trials in the UK