Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Ohio State University Comprehensive Cancer Center
You may qualify if…
- ✓ 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 of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia)
- ✓ Massive (\>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
- ✓ Massive nodes (\>= 10 cm) or progressive or symptomatic lymphadenopathy
- ✓ Progressive lymphocytosis with a lymphocyte doubling time \< 6 months or an increase of \>= 50% over a 2 month period
You may not qualify if…
- ✕ Patients with high-risk disease as defined by:
- ✕ Presence of deletion 17p13 on cytogenetic analysis by fluorescent in situ hybridization (FISH)
- ✕ Presence of TP53 mutation on next generation sequencing
- ✕ Presence of complex karyotype on cytogenetic evaluation
- ✕ Defined as \>= 3 karyotypic abnormalities
- ✕ Treatment with a moderate or strong CYP3A inhibitor or inducer within 7 days prior to first dose of acalabrutinib or venetoclax or need for treatment with a strong CYP3A inhibitor or inducer during the period or the study. Patients who have a need for treatment with a moderate CYP3A inhibitor or inducer during acalabrutinib or venetoclax dose escalation will also be excluded
- ✕ Known active involvement of the central nervous system by lymphoma or leukemia
- ✕ Subject with other malignancies that are associated with a life expectancy of \< 2 years or that would confound assessment of toxicity in this study
Where it's recruiting
Columbus
Source: ClinicalTrials.gov · NCT05336812 · last updated 2026-02-19