OHSU Knight Cancer Institute
This phase Ib trial tests the safety and effectiveness of tafasitamab, acalabrutinib, and obinutuzumab in treating patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). CLL and SLL are types of cancer that develops from a specific white blood cell called B cells or B lymphocytes. Tafasitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell cancers such as CLL at abnormal levels. This may help keep cancer cells from growing and spreading. Giving tafasitamab, acalabrutinib, and obinutuzumab may kill more cancer cells in patients with previously untreated CLL and SLL.
PRIMARY OBJECTIVE: I. Evaluate safety and measurable residual disease negativity. SECONDARY OBJECTIVE: I. Evaluate early indications of efficacy based on response. EXPLORATORY OBJECTIVES: I. Determine progression-free survival. II. Determine overall survival. III. Define the population based on molecular correlates and determinants of CLL or SLL. IV. Associations between molecular correlates and determinants of CLL/SLL and response. V. Correlative Studies for T cell function. VI. Patient-reported quality of life (QOL) outcomes. OUTLINE: Patients receive obinutuzumab intravenously (IV)…
Participant Inclusion Criteria * Written informed consent. Participant or legally authorized representative (LAR) must provide written informed consent prior to any study-specific procedures or interventions * Age \>= 18 years. All genders, races, and ethnic groups will be included * Ability to swallow and retain oral medication * Documented previously untreated CLL/SLL. Diagnosis must be confirmed by peripheral blood flow cytometry or lymph node biopsy and made in accordance with international workshop (iw)CLL diagnostic criteria * Baseline detectable immunoglobulin heavy (IGH) gene signatur…
Given PO
Undergo blood sample collection
Undergo bone marrow biopsy and/or aspiration
Undergo bone marrow biopsy and/or aspiration
Undergo CT scan
Undergo ECHO
Given IV
Ancillary studies
Given IV
Arctuva estimate
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