The study will measure the safety, tolerability, and efficacy with acalabrutinib in combination with rituximab in treatment-naïve elderly and/or frail patients with diffuse large B-cell lymphoma (DLBCL), who are otherwise unsuitable for standard front line chemoimmunotherapy treatments.
Treatment-naïve elderly and/or frail patients with DLBCL will be treated with acalabrutinib in combination with rituximab in a single arm. Study details include the following: * The study duration will be up to 108 weeks for each patient, including up to 28 days for screening and 104 weeks of treatment and follow-up. * The treatment duration will be up to 8 cycles for rituximab and 28 cycles for acalabrutinib both beginning at cycle 1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Patients will receive acalabrutinib orally with dosing schedule of X.
Patients will receive rituximab via IV infusion on Cycle 1 Day 15 and via SC injection on Day 1 of Cycle 2 through Cycle 8.
Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs)
Time frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) through End of treatment EoT [30 days of discontinuation] (Up to 3.5 Years)
Objective response rate (ORR)
Time frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years)
Progression free survival (PFS)
Time frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years)
Event-Free Survival (EFS)
Time frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years)
Overall survival (OS)
Time frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until Post-treatment follow-up (Up to 3.5 Years)
Duration of response (DoR)
Time frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years)
Change from baseline in Timed Up and Go test (TUG)
Time frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until Post-treatment follow-up (Up to 3.5 Years)
Number of patients with adverse events
Time frame: Screening (up to 28 days before day 1) Until Post-treatment follow-up (Up to 3.5 Years)
AstraZeneca Clinical Study Information Center
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Research Site
Berkeley, California, United States
WITHDRAWNResearch Site
La Jolla, California, United States
COMPLETEDResearch Site
Orange, California, United States
ACTIVE_NOT_RECRUITINGResearch Site
Stamford, Connecticut, United States
WITHDRAWNResearch Site
Jacksonville, Florida, United States
ACTIVE_NOT_RECRUITINGResearch Site
Des Moines, Iowa, United States
RECRUITINGResearch Site
Lexington, Kentucky, United States
WITHDRAWNResearch Site
Beltsville, Maryland, United States
ACTIVE_NOT_RECRUITINGResearch Site
Towson, Maryland, United States
ACTIVE_NOT_RECRUITINGResearch Site
Detroit, Michigan, United States
ACTIVE_NOT_RECRUITING...and 47 more locations