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A Phase 3, Open-Label, Randomized Study of LOXO-305 versus Investigator Choice of BTK Inhibitor in Patients with Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN-MCL-321)
Cancer Categories
Hematologic (Blood Cancers)
Karmanos Trial ID
2021-072
NCT ID
NCT04662255
Age Group
Adult
Scope
National
Phase
Phase III
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
Phase III
Principal Investigator
Dipenkumar
Modi, M.D.
Oncology - Hematology, Oncology - Medical
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Objective:
Primary Objective:
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)
Secondary Objectives:
To compare efficacy of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
To evaluate the safety and tolerability of each treatment arm
To evaluate the patient-reported outcomes
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
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
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Non-Hodgkin Lymphoma
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy
Drugs
Acalabrutinib; Ibrutinib; LOXO-305; Zanubrutinib
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