At a glance
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A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (≥ 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)
In Brief
A Phase 3 clinical trial evaluating Bendamustine Hydrochloride, Biospecimen Collection, and 7 other interventions for Stage I Chronic Lymphocytic Leukemia and 3 related conditions. Active but no longer recruiting, targeting 547 participants across 940 sites in 2 countries.
Detailed Summary
This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.
Study Details
Timeline
Interventions
Given IV
Undergo blood sample collection
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Undergo CT
Given PO
Correlative studies
Ancillary studies
Given IV