The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Oral
Oral
Intravenous (IV)
Ironwood Physicians, Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
University of California Irvine Medical Center
Orange, California, United States
Scripps Mercy Hospital
San Diego, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B)
Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018
Time frame: Up to approximately 5 years
To evaluate the efficacy of Arm A compared to Arm B: Progression-free survival (PFS)
Assessments of efficacy include PFS, assessed by investigator
Time frame: Up to approximately 5 years
To evaluate the efficacy of Arm A compared to Arm B: Overall survival (OS)
Assessments of efficacy include OS
Time frame: Up to approximately 5 years
To evaluate the efficacy of Arm A compared to Arm B: Time to next treatment (TTNT)
Assessments of efficacy include TTNT
Time frame: Up to approximately 5 years
To evaluate the efficacy of Arm A compared to Arm B: Event-free survival (EFS)
Assessments of efficacy include EFS
Time frame: Up to approximately 5 years
To evaluate the efficacy of Arm A compared to Arm B: Overall response rate (ORR)
Assessments of efficacy include ORR
Time frame: Up to approximately 5 years
To evaluate the efficacy of Arm A compared to Arm B in patient-reported disease-related symptoms
Based on time to worsening of CLL/SLL-related symptoms
Time frame: Up to approximately 5 years
To evaluate the efficacy 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
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