Study Comparing BGB-16673 with Other Treatments for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Sponsor: BeiGene
ClinicalTrials ID:NCT06846671
This clinical trial is testing a new drug, BGB-16673, against other treatments chosen by doctors for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have already tried certain other medications.
Patient Parameters
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Program Overview
The study aims to find out if BGB-16673 is safe and effective compared to other treatments chosen by doctors for people with CLL or SLL. These patients have already been treated with two types of medications: BTK inhibitors and BCL2 inhibitors. The trial will compare how long patients can live without their cancer getting worse when taking BGB-16673 versus other treatments like idelalisib with rituximab, bendamustine with rituximab, or venetoclax with rituximab.
Description
Chronic lymphocytic leukemia (CLL) is a type of blood cancer that can cause symptoms like swollen lymph nodes, night sweats, weight loss, and fever. People with CLL often have a shorter life expectancy, so new treatments are needed to help manage the disease and improve quality of life.
In this study, patients with CLL or small lymphocytic lymphoma (SLL) who have already tried treatments called BTK inhibitors and BCL2 inhibitors will receive either the new drug BGB-16673 or another treatment chosen by their doctor. The other treatments may include idelalisib with rituximab, bendamustine with rituximab, or venetoclax with rituximab.
The main goal is to see how long patients can live without their cancer getting worse when taking BGB-16673 compared to the other treatments. About 250 patients from around the world will participate in this study, and they will be randomly assigned to receive either BGB-16673 or one of the other treatments.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that needs treatment.
- Have previously been treated with both a BTK inhibitor and a BCL2 inhibitor.
- If you have SLL, your disease must be measurable by a CT or MRI scan.
- Be in relatively good health with an ECOG score of 0, 1, or 2, which means you are fully active or have some restrictions but can still do light work.
- Have adequate liver function.
- Have normal blood clotting ability.
Exclusion Criteria
- Have a type of leukemia called prolymphocytic leukemia or a history of Richter's transformation.
- Have had a stem cell transplant or CAR-T cell therapy in the last 3 months.
- Have cancer that has spread to the central nervous system.
- Have been treated with any BTK protein degraders before.
- Have an active infection that requires intravenous treatment.
- Have significant heart disease.
Note: There may be other criteria for inclusion or exclusion as defined by the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cleveland Clinic Florida | 33331-3609 | Weston | Florida |
| Emory University Winship Cancer Institute | 30322-1013 | Atlanta | Georgia |
| Our Lady of the Lake Hospital | 70808-4365 | Baton Rouge | Louisiana |
| Clinical Research Alliance, Inc | 11590-5119 | Westbury | New York |
| University Hospitals | 44106-1716 | Cleveland | Ohio |
| Texas Oncology Tyler | 75702-7522 | Tyler | Texas |
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