A Phase 1b, Multicenter, Open-label Study of Acalabrutinib in Combination with Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in Subjects with Mantle Cell Lymphoma
This is a multicenter, open-label Phase 1b study to assess the safety and efficacy of acalabrutinib when administered concomitantly with bendamustine and rituximab in subjects with treatment naive or relapse refractory mantle cell lymphoma (Part 1), or when administered concomitantly with venetoclax and rituximab in subjects with treatment naive mantle cell lymphoma (Part 2).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Research Site
Louisville, Kentucky, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Hackensack, New Jersey, United States
Number of Participants with Treatment Emergent Adverse Events (AEs) as assessed by CTCAE v4.03
Number of participants who had experienced at least one treatment emergent AE
Time frame: From first dose of study drug to within 30 days of last dose of study drug
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Research Site
Morristown, New Jersey, United States
Research Site
Lake Success, New York, United States
Research Site
Columbus, Ohio, United States
Research Site
Nashville, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Seattle, Washington, United States
Research Site
Seattle, Washington, United States
...and 5 more locations