To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Research Site
Los Angeles, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
New York, New York, United States
Research Site
Columbus, Ohio, United States
Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.
Time frame: SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.
Area Under the Plasma Concentration (AUC)
To Characterize the Pharmacokinetic parameter AUC of acalabrutinib
Time frame: 1 Cycle (28 days)
Maximum Observed Plasma Concentration (Cmax)
To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib
Time frame: 1 Cycle (28 days)
Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)
To evaluate the concentration pharmacodynamic effects of acalabrutinib
Time frame: 2 Cycles (1 cycle = 28 days) and at end of treatment
Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR)
To evaluate the activity of acalabrutinib as measured by ORR
Time frame: From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days)
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Research Site
Houston, Texas, United States
Research Site
Leicester, United Kingdom
Research Site
Plymouth, United Kingdom