Venetoclax + Obinutuzumab for Leukemia
Trial Summary
What is the purpose of this trial?
This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax 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. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any prior CLL-directed therapy or strong CYP3A4/5 inhibitors or inducers. It's best to discuss your current medications with the trial team.
How is the drug combination of Venetoclax and Obinutuzumab unique for treating chronic lymphocytic leukemia?
The combination of Venetoclax and Obinutuzumab is unique because it offers a chemotherapy-free option for treating chronic lymphocytic leukemia, particularly for patients who are not fit for intensive chemoimmunotherapy. This treatment targets cancer cells more precisely by inhibiting BCL2, a protein that helps cancer cells survive, and has shown higher rates of undetectable minimal residual disease and longer progression-free survival compared to traditional chemoimmunotherapy.12345
Research Team
Deborah M Stephens
Principal Investigator
SWOG Cancer Research Network
Eligibility Criteria
This trial is for adults diagnosed with high-risk CLL or SLL within the last year, who have not received prior CLL-directed therapy. They must have certain genetic markers, adequate organ function, and no active hepatitis B or C. Participants should be able to take oral medications and agree to quality of life assessments if they can complete forms in specified languages.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive venetoclax and obinutuzumab. Obinutuzumab is administered intravenously on specific days of the cycle, and venetoclax is taken orally daily for 12 cycles.
Follow-up
Participants are monitored for safety, effectiveness, and overall survival after treatment completion.
Treatment Details
Interventions
- Obinutuzumab
- Venetoclax
Obinutuzumab is already approved in United States, European Union for the following indications:
- Chronic Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
- Chronic Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor