This research study is studying a combination of drugs as a possible treatment for chronic
lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The names of the study drugs involved in this study are:
This research study is a Phase II clinical trial. Phase II clinical trials test the safety
and effectiveness of investigational drugs to learn whether the drugs work in treating a
specific disease. "Investigational" means that the drugs are being studied.
The U.S. Food and Drug Administration (FDA) has approved  venetoclax- obinutuzumab and 
acalabrutinib individually as treatment options for chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL). However, the combination of all 3 drugs has not yet been
approved by the FDA.
Venetoclax is a targeted therapy drug that works by blocking a protein called Bcl-2 in
cancer cells. Bcl-2 helps cancer cells survive and resist the effects of cancer
treatments. By blocking Bcl-2, venetoclax may kill cancer cells and/or make them more
open to the effects of other cancer treatments.
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. 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.
Acalabrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK). BTK is a
protein inside of the cell that may be over-expressed in malignant B cells. It is
involved in the signaling pathway from the B-cell receptor. BTK inhibition caused by
taking acalabrutinib results in decreased malignant B-cell growth and survival.
On this study, participants will receive obinutuzumab and venetoclax. We will monitor for
minimal residual disease (MRD) using a test called "Adaptive ClonoSEQ" after treatment with
obinutuzumab and venetoclax. MRD is a molecular test, which can detect whether there is any
evidence of CLL/SLL in the blood or bone marrow. For participants with detectable MRD despite
treatment with obinutuzumab and venetoclax, acalabrutinib will be added with the goal of
achieving undetectable MRD. Additionally, for participants who have progressive CLL/SLL
despite venetoclax and obinutuzumab, acalabrutinib will be added.
The research study procedures include screening for eligibility, study treatment, end of
treatment visit, follow-up visits and an off-study visit.
Participants will receive study treatment for 2 or 3 years.
Participants will be followed for 2 years after completion of the study.
It is expected that 40 people will take part in this research study
Genentech is supporting this research study by providing venetoclax and obinutuzumab.
small lymphocytic lymphoma, chronic lymphocytic leukemia (cll), Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, leukemia chronic lymphocytic, b-cell small lymphocytic lymphoma
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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