Prospective Randomized Phase II Study of Acalabrutinib + Obinutuzumab or Venetoclax in Previously Untreated CLL
Ohio State University Comprehensive Cancer Center
Summary
This phase II trial tests whether acalabrutinib in combination with venetoclax or obinutuzumab works to shrink tumors in patients with treatment-naive chronic lymphocytic leukemia . Acalabrutinib is also an inhibitor that works in the body to block the activation of certain cells that lead to the growth of cancerous B cells. 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. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib in combination with venetoclax or obinutuzumab may help ease symptoms, decrease the amount of cancer suggestive of improvement, prolonged disease-free remission and/or survival, and increased knowledge about cancer treatment in patients with chronic lymphocytic leukemia. Patients will be treated with acalabrutinib for 12 cycles, and then randomized to receive 6 cycles of acalabrutinib plus obinutuzumab or acalabrutinib plus venetoclax.
Description
PRIMARY OBJECTIVE: I. To evaluate whether the addition of venetoclax or obinutuzumab for 6 cycles to patients receiving acalabrutinib for 1 year in treatment-naive (TN) chronic lymphocytic leukemia (CLL) will improve rate of bone marrow (BM) undetectable minimal residual disease (uMRD). SECONDARY OBJECTIVES: I. To assess the safety and tolerability of a delayed approach to combination therapy in patients with TN CLL. II. To determine the overall response rate (ORR) of the addition of venetoclax or obinutuzumab for 6 cycles to patients receiving acalabrutinib for 1 year in TN CLL. III. To…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Men and women \>= 18 years of age * Diagnosis of CLL/small lymphocytic lymphoma (SLL) meeting criteria established in the 2018 International Workshop (iw)CLL guidelines * Must be treatment-naive: Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control * Patients must meet criteria for treatment as defined by 2018 iwCLL guidelines which includes at least one of the following criteria: * Evidence…
Interventions
- DrugAcalabrutinib
Given PO
- BiologicalObinutuzumab
Given IV
- DrugVenetoclax
Given PO
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio