Randomized Phase II Study of Intermittent Versus Continuous Venetoclax Therapy With Acalabrutinib in Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This
Zulfa Omer
Summary
This is a randomized Phase II study of intermittent versus continuous venetoclax therapy with Acalabrutinib in previously untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Description
This study is a two-arm, open label, Phase II multicenter clinical trial designed to evaluate the intermittent and continuous venetoclax + acalabrutinib in 2 arms in previously untreated CLL/SLL. Phase II trial will be in two separate arms using Simon's 2-stage design for each. Subjects will be randomized with 2:1 ratio into Arm A which will receive intermittent venetoclax (7days administration per cycle) + acalabrutinib and Arm B which will receive continuous venetoclax (28 days administrations per cycle) + acalabrutinib. With this trial we are seeking to establish efficacy of the combinati…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) as defined by the IWCLL including variation of flow cytometry, provided cytogenetic or mutational data are supportive of CLL/SLL diagnosis that requires therapy by one IWCLL criteria; and, must be previously untreated CLL/SLL. a. Note: Variation in flow cytometry is defined as patients who have atypical immunophenotyping for CLL (CD5 negative, CD23 negative or surface expression of CD79b that is bright) but clinically behave like CLL (leukocytosis, lymphadenopathy and splenomegaly) a…
Interventions
- DrugVenetoclax
intermittent venetoclax (7days administration per cycle) + acalabrutinib
- DrugAcalabrutinib
intermittent venetoclax (7days administration per cycle) + acalabrutinib
- DrugVenetoclax
continuous venetoclax (28 days administrations per cycle) + acalabrutinib
- DrugAcalabrutinib
continuous venetoclax (28 days administrations per cycle) + acalabrutinib
Location
- University of CincinnatiCincinnati, Ohio