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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
309
To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B)
Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria
Time frame: Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS)
Assessments of effectiveness include PFS, assessed by investigator
Time frame: Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS)
Assessments of effectiveness include OS, assessed by investigator
Time frame: Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT)
Assessments of effectiveness include TTNT, assessed by investigator
Time frame: Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR)
Assessments of effectiveness include ORR, assessed by investigator and IRC
Time frame: Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR)
Assessments of effectiveness include DOR, assessed by investigator and IRC
Time frame: Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms
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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
...and 98 more locations
Based on time to worsening of CLL/SLL-related symptoms
Time frame: Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning
Based on time to worsening of physical functioning
Time frame: Up to approximately 5 years