A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects < or =75 Years with Previously Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Closed
Phase: III
Principal Investigator: Bociek, R Gregory
Contact Information:
Susan Blumel, RN
402-559-9183
sblumel@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04529772?term=NCT04529772&rank=1
Summary
Primary Objective
To evaluate if the addition of acalabrutinib to R-CHOP prolongs PFS, as compared with placebo plus R-CHOP alone in subjects < or =65 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP, based on investigator-assessed response.
Secondary Objectives
To evaluate event-free survival (EFS) with acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in subjects < or =65 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP, as assessed by investigator.
To evaluate CR rate at end of study treatment with acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in subjects < or =65 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP, as assessed by BICR.
To evaluate overall survival (OS) with acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in subjects < or =65 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP.
To evaluate PFS with acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in subjects < or =65 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP, as assessed by BICR.
To evaluate PFS at the 3-year landmark with acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in subjects < or =65 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP, as assessed by investigator and BICR.
To evaluate event-free survival (EFS) with acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in subjects < or =65 with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP, as assessed by BICR.
To evaluate CR rate at end of treatment with acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in subjects < or =65 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP, as assessed by investigator.
To evaluate the safety and tolerability of acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in subjects < or =65 with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP.
To characterize the pharmacokinetics of acalabrutinib and its metabolite (ACP-5862) when acalabrutinib is administered in combination with R-CHOP in subjects < or =65 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP.
Exploratory Objectives
To evaluate the efficacy of acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in non-GCB subjects as classified using methods other than GEP.
To evaluate additional potential predictive biomarkers of response and resistance to the investigational study treatment.
To assess minimal residual disease (MRD) detectability to understand depth of response from circulating tumor DNA (ctDNA)/whole blood monitoring
To evaluate acalabrutinib plus R-CHOP relative to placebo plus R-CHOP based on clinical outcome assessments (COAs) related to wellbeing and general health status.