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Protocol NumberJ2N-OX-JZNM (LOXO-BTK-20019)
NCT Number(ClinicalTrials.gov Identfier)NCT04662255
Active

2021-03-17 - 2027-01-15

Phase III

Recruiting8

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)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator HSUAN JEN SHIH Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳宇欽 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tai-Chung Huang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jyh-Pyng Gau Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hui-Hua Hsiao Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳志丞 Division of Hematology & Oncology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Lymphoma, Mantle-Cell

Objectives

The objectives of this study are as follows: 1. To determine the duration of any benefits derived from LOXO-305 treatment (Group A) compared to ibrutinib, acalabrutinib, or zanubrutinib (Group B) selected by the trial administrator. 2. To determine how well MCL patients respond to LOXO-305 treatment compared to ibrutinib, acalabrutinib, or zanubrutinib selected by the trial administrator. 3. To determine the safety profile of LOXO-305 compared to ibrutinib, acalabrutinib, and zanubrutinib. 4. To determine how well patients feel about receiving LOXO-305 compared to ibrutinib, acalabrutinib, or zanubrutinib.

Test Drug

錠劑

Active Ingredient

PIRTOBRUTINIB

Dosage Form

110

Dosage

200mg

Endpoints

Primary: Compare progression-free survival (PFS) in patients with previously treated mantle cell lymphoma (MCL) using LOXO-305 as monotherapy (Group A) versus administrator-selected covalently BTK inhibitor monotherapy (Group B).

Secondary: Compare the efficacy of LOXO-305 as monotherapy (Group A) versus administrator-selected covalently BTK inhibitor monotherapy (Group B).

Assess the safety and tolerability of each treatment group.
Assess patient-reported outcomes – (relative tolerability: proportion of time with high side effect burden; time to MCL-related symptom exacerbation (TTW)).

Inclution Criteria

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

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

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    500 participants

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