Tacabrutideg + Sonrotoclax + Obinutuzumab for Chronic Lymphocytic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial tests how well tacabrutideg and sonrotoclax, with response-guided addition of obinutuzumab, works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Tacabrutideg is a drug that degrades a protein called Bruton's tyrosine kinase (BTK). By degrading BTK, tacabrutideg inhibits the activation of signaling pathways that help cancer cells survive, inhibiting the growth of cancer cells that express the BTK protein. Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving tacabrutideg together with sonrotoclax may kill more cancer cells than giving either drug alone, and giving obinutuzumab after initial treatment with tacabrutideg and sonrotoclax may improve disease response in patients whose CLL or SLL didn't respond completely to initial treatment.
Who Is on the Research Team?
Jennifer J. Huang, MD, PhD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Participants should be able to undergo study procedures and not have other serious health issues that would prevent participation.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Obinutuzumab
- Sonrotoclax
- Tacabrutideg
Trial Overview
The study tests a combination of two drugs, tacabrutideg and sonrotoclax, in people with CLL/SLL. If the cancer doesn't fully respond at first, obinutuzumab may be added. The goal is to see if this approach works better than using each drug alone.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive tacabrutideg PO QD on days 1-28 of cycles 1-14 and sonrotoclax PO QD on days 1-28 of cycles 3-14. Cycles repeat every 28 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients who are MRD positive after cycle 14 continue receiving tacabrutideg PO QD and sonrotoclax PO QD on days 1-28 of cycles 15-20 and also receive obinutuzumab IV on days 8, 9, 15 and 22 of cycle 15 and day 8 of cycles 16-20. Cycles repeat every 28 days for up to 6 additional cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo TTE or MUGA at screening and undergo CT and collection of blood samples throughout the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Center
Lead Sponsor
BeOne Medicines
Industry Sponsor
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