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A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) plus Venetoclax and Rituximab versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-322)

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

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 Call Center

IQVIA Services Japan G.K.

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

+81-3-6859-9500

loxo-btk-20022_jpn_cliops@iqvia.com

Not Recruiting

Jan. 08, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
Platelets greater than or equal to (>=)50 x 10^9/liter (L), hemoglobin >=8 grams/deciliter (g/dL) and absolute neutrophil count >=1.0 x 10^9/L
Adequate organ function
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Estimated creatinine clearance >=30 milliliters per minute (mL/min)

Known or suspected Richter's transformation at any time preceding enrollment
Prior therapy with a non-covalent (reversible) BTK inhibitor
Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
Prior therapy with venetoclax
Central nervous system (CNS) involvement
Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
Active hepatitis B or hepatitis C
Known active cytomegalovirus (CMV) infection
Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
Significant cardiovascular disease
Vaccination with a live vaccine within 28 days prior to randomization
Patients with the following hypersensitivity:

Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
Prior significant hypersensitivity to rituximab
Known allergy to allopurinol and inability to take uric acid lowering agent

Both

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Drug: Pirtobrutinib
Oral
Other Names:
LOXO-305
LY3527727
Drug: Venetoclax
Oral
Other Names:
Venclexta
Venclyxto
Drug: Rituximab
Intravenous (IV)
Other Names:
Rituxan
MabThera
Truxima
Riabni
Ruxience

[Study Arms]
Experimental: Arm A (PVR)
Fixed duration pirtobrutinib in combination with venetoclax and rituximab
Interventions:
Drug: Pirtobrutinib
Drug: Venetoclax
Drug: Rituximab
Active Comparator: Arm B (VR)
Venetoclax with rituximab
Interventions:
Drug: Venetoclax
Drug: Rituximab

To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax 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

+81-11-706-7061

July. 20, 2021

No

United States/Italy/Australia/Spain/Germany/Belgium/Canada/Czech Republic/Denmark/France/Hungary/Ireland/Israel/Poland/South Korea/Sweden/Switzerland/Taiwan/United Kingdom/Singapore/China