臨床研究等提出・公開システム

A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naive Mantle Cell Lymphoma (BRUIN MCL-321)

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

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

IQVIA Services Japan G.K. jRCT Inquiry Contact

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo

+81-3-6859-9500

JP_LOXO-BTK-20019_20020_CRA@iqvia.com

Not Recruiting

Aug. 13, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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

- 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

Both

Lymphoma, Mantle-Cell

Drug: Pirtobrutinib
Oral
Other Names:
LOXO-305
LY3527727
Drug: Ibrutinib
Oral
Other Name: Imbruvica
Drug: Acalabrutinib
Oral
Other Name: Calquence
Drug: Zanubrutinib
Oral
Other Name: Brukinsa

[Study Arms]
Experimental: Arm A (Pirtobrutinib)
Orally
Intervention: Drug: Pirtobrutinib
Active Comparator: Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)
Investigator's choice (based on local availability) of ibrutinib, acalabrutinib or zanubrutinib orally. Options are limited to those that are available/approved in the specific country.
Interventions:
Drug: Ibrutinib
Drug: Acalabrutinib
Drug: Zanubrutinib

To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL) [ Time Frame: Up to approximately 24 months ]
Assessed per Lugano criteria

+81-22-717-7000

Mar. 22, 2021

No

Australia/Austria/Belgium/Brazil/Canada/China/Czechia/Denmark/France/Germany/Hungary/Ireland/Israel/Italy/Republic of Korea/Netherlands/New Zealand/Poland/Portugal/Russian Federation/Spain/Switzerland/Taiwan/United Kingdom/United States