Study Comparing Pirtobrutinib (LOXO-305) and Bendamustine Plus Rituximab for Untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Sponsor: Loxo Oncology, Inc.
ClinicalTrials ID:NCT05023980
This clinical trial is evaluating the effectiveness and safety of a new drug, pirtobrutinib (LOXO-305), compared to a standard treatment combination of bendamustine and rituximab in patients with CLL or SLL who have not received any prior treatment. The study may last up to five years.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to see how well pirtobrutinib (LOXO-305) works compared to the combination of bendamustine and rituximab in treating patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have not been treated before. Researchers will also look at the safety of these treatments. Participants may be involved in the study for up to five years.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of CLL or SLL that requires treatment.
- Be in good general health with an ECOG performance status of 0 to 2, meaning fully active or able to carry out light work.
- Have adequate organ function.
- Have sufficient blood cell counts, including platelets, hemoglobin, and neutrophils.
- Have good kidney function with a creatinine clearance of at least 40 mL/min.
Exclusion Criteria
- Have had a transformation to a more aggressive form of lymphoma known as Richter's transformation.
- Have received any previous treatment for CLL or SLL.
- Have a specific genetic abnormality called 17p deletion.
- Have cancer that has spread to the brain or spinal cord.
- Have uncontrolled autoimmune blood disorders.
- Have significant heart disease.
- Have active hepatitis B or C infections.
- Have an active cytomegalovirus (CMV) infection.
- Have an active, uncontrolled infection.
- Have HIV infection.
- Are currently using other experimental drugs or cancer treatments, except for hormonal therapy.
- Require blood thinners like warfarin.
- Have received a live vaccine within 28 days before starting the study.
- Have known allergies to any components of pirtobrutinib, bendamustine, or rituximab.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| California Research Institute | 90027 | Los Angeles | California |
| Innovative Clinical Research Institute | 90603 | Whittier | California |
| Oncology-Hematology Associates of West Broward | 33065 | Coral Springs | Florida |
| New Jersey Center for Cancer Research | 08724 | Brick | New Jersey |
| Clinical Research Alliance, Inc. | 11590 | Westbury | New York |
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