JRCT ID: jRCT2021210026
Registered date:13/08/2021
A Phase 3 Study of LOXO-305 in Patients with Mantle Cell Lymphoma
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Mantle Cell Lymphoma |
Date of first enrollment | 04/11/2021 |
Target sample size | 22 |
Countries of recruitment | United States,Japan,Australia,Japan,Belgium,Japan,Canada,Japan,France,Japan,Israel,Japan,New Zealand,Japan,Poland,Japan,Portugal,Japan,Spain,Japan,United Kingdom,Japan |
Study type | Interventional |
Intervention(s) | Investigational drug LOXO-305 or Iburutinib for oral administration |
Outcome(s)
Primary Outcome | Progression-free survival(PFS) per Lugano criteria |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 x 109/L): independent of growth factor support within 7 days of Screening assessment - Hemoglobin >= 8 g/dL: independent of transfusions, and of growth factor support within 7 days of Screening assessment - Platelets >= 50 x 109/L: independent of transfusions, and of growth factor support within 7 days of Screening assessment - 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 |
Exclude 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 |
Related Information
Primary Sponsor | Ito Rodrigo |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | jRCT Inquiry Contact IQVIA Services Japan K.K. |
Address | 4-10-18 Takanawa, Minato-ku, Tokyo Tokyo Japan 108-0074 |
Telephone | +81-3-6859-9500 |
JP_LOXO-BTK-20019_20020_CRA@iqvia.com | |
Affiliation | IQVIA Services Japan K.K. |
Scientific contact | |
Name | Rodrigo Ito |
Address | Lilly Corporate Center, Indianapolis IN 46285 USA Japan 46285 |
Telephone | 1-862-253-8562 |
clinicaltrials@loxooncology.com | |
Affiliation | Eli Lilly and Company |