NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedMantle Cell Lymphoma
Date of first enrollment04/11/2021
Target sample size22
Countries of recruitmentUnited 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 typeInterventional
Intervention(s)Investigational drug LOXO-305 or Iburutinib for oral administration

Outcome(s)

Primary OutcomeProgression-free survival(PFS) per Lugano criteria
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
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

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
E-mail 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
E-mail clinicaltrials@loxooncology.com
Affiliation Eli Lilly and Company