A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
- Conditions
- Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
- Interventions
- Registration Number
- NCT05023980
- Lead Sponsor
- Loxo Oncology, Inc.
- Brief Summary
The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 309
- 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 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B (BR) Rituximab Bendamustine plus rituximab administered intravenously (IV) Arm A (Pirtobrutinib) Pirtobrutinib Pirtobrutinib administered orally Arm B (BR) Bendamustine Bendamustine plus rituximab administered intravenously (IV)
- Primary Outcome Measures
Name Time Method To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B) Up to approximately 5 years Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria
- Secondary Outcome Measures
Name Time Method To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS) Up to approximately 5 years Assessments of effectiveness include PFS, assessed by investigator
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms Up to approximately 5 years Based on time to worsening of CLL/SLL-related symptoms
To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT) Up to approximately 5 years Assessments of effectiveness include TTNT, assessed by investigator
To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS) Up to approximately 5 years Assessments of effectiveness include OS, assessed by investigator
To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR) Up to approximately 5 years Assessments of effectiveness include ORR, assessed by investigator and IRC
To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR) Up to approximately 5 years Assessments of effectiveness include DOR, assessed by investigator and IRC
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning Up to approximately 5 years Based on time to worsening of physical functioning
Trial Locations
- Locations (108)
California Research Institute
🇺🇸Los Angeles, California, United States
Innovative Clinical Research Institute
🇺🇸Whittier, California, United States
Oncology-Hematology Associates of West Broward
🇺🇸Coral Springs, Florida, United States
New Jersey Center for Cancer Research
🇺🇸Brick, New Jersey, United States
Clinical Research Alliance, Inc.
🇺🇸Westbury, New York, United States
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Westmead Hospital
🇦🇺Wentworthville, New South Wales, Australia
Peninsula Private Hospital
🇦🇺Frankston, Victoria, Australia
Uniklinikum Salzburg
🇦🇹Salzburg, Austria
Klinik Ottakring
🇦🇹Vienna, Austria
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