Study Comparing Pirtobrutinib with Venetoclax and Rituximab to Venetoclax and Rituximab Alone in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Sponsor: Loxo Oncology, Inc.
ClinicalTrials ID:NCT04965493
This clinical trial is testing whether adding the drug Pirtobrutinib to the standard treatment of Venetoclax and Rituximab is more effective and safe for patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma who have already received treatment. The study may last up to five years.
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Program Overview
The aim of this study is to see if a new drug combination, Pirtobrutinib with Venetoclax and Rituximab, works better and is safer than the usual treatment of Venetoclax and Rituximab alone for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have been treated before. Participants may be involved in the study for up to five years.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that needs treatment.
- Have received at least one previous treatment, which may include a specific type of medication called a covalent BTK inhibitor.
- Have a platelet count of at least 50 x 10⁹/L, hemoglobin level of at least 8 g/dL, and a neutrophil count of at least 1.0 x 10⁹/L.
- Have good organ function.
- Have an ECOG performance status score between 0 and 2, indicating full activity or some restriction in strenuous activities.
- Have an estimated creatinine clearance of at least 30 mL/min, indicating adequate kidney function.
Exclusion Criteria
- Have had a transformation to a more aggressive form of lymphoma known as Richter's transformation.
- Have previously been treated with a non-covalent BTK inhibitor.
- Require blood thinners like warfarin or other Vitamin K antagonists.
- Are currently taking strong medications that affect liver enzymes (CYP3A4 inhibitors or inducers).
- Have previously been treated with Venetoclax.
- Have cancer that has spread to the brain or spinal cord.
- Have an active, uncontrolled infection.
- Have HIV infection, regardless of immune cell count.
- Have had a stem cell transplant or CAR-T therapy within the last 60 days.
- Have active hepatitis B or C.
- Have an active cytomegalovirus (CMV) infection.
- Have uncontrolled immune-related blood disorders like ITP or AIHA.
- Have significant heart disease.
- Have received a live vaccine within the last 28 days.
- Have allergies to any components of the study drugs or have had significant allergic reactions to Rituximab or Allopurinol.
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