Trial Details 31 Total Sites

A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation

This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale [CIRS]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).

phase

Phase 3

status

Recruiting

enrollment

165

score

34

start date

2020-05-28

last updated

2022-01-10

biomarkers

N/A

Austin, Texas
facility
Southwest Regional Cancer Center
1 facility
Recruiting
Aurora, Colorado
facility
Medical Center of Aurora; Rocky Mountain Cancer Centers
1 facility
Recruiting
Amarillo, Texas
facility
Texas Oncology West
1 facility
Recruiting
Knoxville, Tennessee
facility
University of Tennessee Medical Center
1 facility
Recruiting
Eugene, Oregon
facility
Oncology Assoc of Oregon, PC
1 facility
Recruiting
McAllen, Texas
facility
South Texas Cancer Center - McAllen
1 facility
Recruiting
Denton, Texas
facility
Texas Oncology-Denton South
1 facility
Recruiting
Billings, Montana
facility
St. Vincent Frontier Cancer Center
1 facility
Recruiting
Tyler, Texas
facility
Texas Oncology, P.A. - Tyler; Tyler Cancer Center
1 facility
Recruiting
Columbia, Maryland
facility
Maryland Oncology Hematology, P.A.
1 facility
Recruiting
Albany, New York
facility
New York Oncology Hematology, P.C.
1 facility
Recruiting
Ogden, Utah
facility
Community Cancer Trials of Utah
1 facility
Recruiting