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A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (J2N-OX-JZNP)

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (J2N-OX-JZNP)

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-20023_CRA@iqvia.com

Not Recruiting

Dec. 09, 2021

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Adequate organ function
- Platelets greater than or equal to (>=)75 X 10^9/liter (L) (>=50 X 10^9/L for patients with evidence of bone marrow infiltrate), hemoglobin >=8 grams/deciliter (g/dL), and absolute neutrophil count >=0.75 X 10^9/L
- Kidney function: Estimated creatinine clearance >=40 milliliters per minute (mL/min)

- Known or suspected Richter's transformation at any time preceding enrollment
- Prior systemic therapy for CLL/SLL
- Presence of 17p deletion
- Central nervous system (CNS) involvement
- Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
- Significant cardiovascular disease
- Active hepatitis B or hepatitis C
- Active cytomegalovirus (CMV) infection
- Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
- Concurrent use of investigational agent or anticancer therapy except hormonal therapy
- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
- Vaccination with a live vaccine within 28 days prior to randomization
- Patients with the following hypersensitivity:
- Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
- Prior significant hypersensitivity to rituximab

Both

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Drug: Pirtobrutinib
Oral
Other Names:
LOXO-305
LY3527727
Drug: Bendamustine
IV
Other Names:
Treanda
Treakisym
Ribomustin
Levact
Drug: Rituximab
IV
Other Names:
Rituxan
MabThera
Truxima
Riabni
Ruxience

[Study Arms]
Experimental: Arm A (Pirtobrutinib)
Pirtobrutinib administered orally
Intervention: Drug: Pirtobrutinib
Active Comparator: Arm B (BR)
Bendamustine plus rituximab administered intravenously (IV)
Interventions:
Drug: Bendamustine
Drug: Rituximab

To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B) [ Time Frame: Up to approximately 5 years ]
Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria

+81-52-951-1111

Sept. 28, 2021

No

Australia/Austria/Brazil/Bulgaria/China/Czechia/France/Hungary/Italy/Republic of Korea/New Zealand/Poland/Portugal/Romania/Russian Federation/Spain/Taiwan/United Kingdom/United States