Zanubrutinib, Obinutuzumab, Sonrotoclax (BOSon) or BGB-16673, Obinutuzumab, Sonrotoclax (DOSon) in TN CLL/SLL
brief summary
The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational \[drug/device/intervention\] to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has approved sonrotoclax for the treatment of patients with mantle cell lymphoma. However, the U.S. FDA has not approved sonrotoclax for the treatment of patients with CLL/SLL.
The U.S. FDA has approved zanubrutinib and obinutuzumab as a treatment option for CLL/SLL.
The U.S. FDA has not approved catadegbrutinib (BGB-16673).
The combinations of zanubrutinib, obinutuzumab, and sonrotoclax (BOSon regimen) or catadegbrutinib (BGB-16673), obinutuzumab, and sonrotoclax (DOSon) are not an approved regimen for CLL or SLL and are investigational in this study.
Zanubrutinib blocks a protein in B-cells (immune cells) called Bruton tyrosine kinase (BTK). BTK helps CLL/SLL cells live and grow. By blocking BTK, zanubrutinib may slow down or stop the activity of CLL/SLL cells, which can lead to improvement in the symptoms associated with CLL/SLL.
Catadegbrutinib (BGB-16673) degrades a protein in B-cells (immune cells) called Bruton tyrosine kinase (BTK). BTK helps CLL/SLL cells live and grow. By degrading BTK, catadebrutinib may slow down or stop the activity of CLL/SLL cells, which can lead to improvement in the symptoms associated with CLL/SLL.
Obinutuzumab is a drug that targets a protein called CD20, which is found on the surface of B cells, the white blood cells that are affected by CLL/SLL. When obinutuzumab attaches to CD20, it directly both destroys the B cells and makes them more "visible" to the immune system. The immune system then attacks and destroys the cancerous B cells.
Sonrotoclax blocks a protein called B-cell lymphoma-2 (Bcl-2). Bcl-2 helps certain blood cancer cells live and replicate. By blocking Bcl-2, sonrotoclax can slow or stop blood cancer cells replicating and allow natural cell death to occur, thereby causing blood cancer cell death.
This research study uses the clonoSEQ test to detect measurable residual disease (MRD). The U.S. Food and Drug Administration (FDA) has approved the clonoSEQ MRD test for patients with CLL/SLL. However, using this test to guide the duration of therapy is investigational in this study. Although we hope that this test can be used to provide a more personalized treatment plan for participants with CLL/SLL, there is also a risk that this results in some participants receiving more or less treatment than they otherwise would receive.
official title
A Multicenter Phase 2 Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax (BOSon) or Catadegbrutinib (BGB-16673), Obinutuzumab, and Sonrotoclax (DOSon) in Treatment-Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma