American Institute of Research | Innovative Clinical Research Institute
Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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:
Primary purpose
Allocation
Interventional model
Masking
250 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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