Venetoclax + Obinutuzumab +/- Acalabrutinib for Chronic Lymphocytic Leukemia
Trial Summary
What is the purpose of this trial?
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: * obinutuzumab * venetoclax * acalabrutinib
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot take strong inhibitors or inducers of CYP3A, CYP2C8, CYP2C9, and CYP2C19 within 7 days before starting the study drugs. Also, avoid grapefruit, Seville oranges, and star fruit within 3 days before starting. If you're on dual antiplatelet therapy or warfarin, you cannot participate.
What data supports the idea that Venetoclax + Obinutuzumab +/- Acalabrutinib for Chronic Lymphocytic Leukemia is an effective drug?
The available research shows that the combination of Venetoclax and Obinutuzumab is effective for treating Chronic Lymphocytic Leukemia. In a study comparing this combination to another treatment (Chlorambucil plus Obinutuzumab), patients who received Venetoclax and Obinutuzumab had longer periods without the disease getting worse. They also had higher rates of the disease being undetectable and better overall responses. Another study found that adding Acalabrutinib to Venetoclax and Obinutuzumab could lead to even deeper and longer-lasting remissions. These findings suggest that Venetoclax and Obinutuzumab, with or without Acalabrutinib, are effective options for treating this type of leukemia.12345
What safety data is available for the treatment of Venetoclax, Obinutuzumab, and Acalabrutinib in CLL?
The combination of Venetoclax and Obinutuzumab has been studied in the CLL14 trial, showing an acceptable tolerability profile with notable adverse events like grade 3 or 4 neutropenia, which can be managed with supportive therapy and dose modifications. The incidence of grade 3-4 neutropenia was reported between 52.8%-57.7%. Acalabrutinib, when added to Venetoclax and Obinutuzumab, is being evaluated for its potential to induce deep and durable remissions in CLL patients, but specific safety data for this triplet combination is not detailed in the provided studies.12346
Is the drug combination of Acalabrutinib, Obinutuzumab, and Venetoclax promising for treating Chronic Lymphocytic Leukemia?
Yes, the drug combination of Acalabrutinib, Obinutuzumab, and Venetoclax is promising for treating Chronic Lymphocytic Leukemia. Venetoclax and Obinutuzumab have shown to be effective in improving progression-free survival and response rates compared to traditional chemotherapy. This combination offers a chemotherapy-free option, which is beneficial for patients who cannot tolerate intensive treatments.12467
Research Team
Jacob D. Soumerai, MD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Adults over 18 with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who need treatment and have previously received systemic therapy. They must be in good enough health, not pregnant, agree to contraception, and not have certain heart conditions or other serious illnesses that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
- Obinutuzumab (Monoclonal Antibodies)
- Venetoclax (B-cell lymphoma-2 (BCL-2) inhibitor)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Genentech, Inc.
Industry Sponsor