A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

August 10, 2018

Primary Completion Date

October 12, 2021

Study Completion Date

July 12, 2023

Conditions
Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)
Interventions
DRUG

Obinutuzumab

Administered via intravenous infusion

DRUG

Bendamustine

Administered via intravenous infusion

DRUG

Venetoclax

The venetoclax dose was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. Venetoclax was continued for a total duration of up to 53 weeks, including the 5-week ramp-up schedule. Participants were instructed to take venetoclax tablets with a meal and water at approximately the same time each day. Venetoclax tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing.

Trial Locations (15)

29615

Prisma Health Cancer Inst - Eastside /ID# 202329, Greenville

64132

MidAmerica Division, Inc. /ID# 201099, Kansas City

75230

Texas Oncology - Medical City Dallas /ID# 201196, Dallas

75702

Texas Oncology - Northeast Texas /ID# 201211, Tyler

78503

Texas Oncology - McAllen /ID# 202331, McAllen

78705

Texas Oncology - Austin Midtown /ID# 201199, Austin

80218

Rocky Mountain Cancer Centers - Denver Midtown /ID# 202328, Denver

98684

Northwest Cancer Specialists, P.C. /ID# 201198, Vancouver

85284-1812

Arizona Oncology Associates, PC-HOPE /ID# 202335, Tempe

45236-2725

Oncology Hematology Care, Inc. /ID# 202397, Cincinnati

97401-6043

Willamette Valley Cancer Institute and Research Center /ID# 201201, Eugene

37404-1108

Tennessee Oncology - Chattanooga /ID# 202840, Chattanooga

37203-1632

Tennessee Oncology-Nashville Centennial /ID# 201098, Nashville

77701-4691

Texas Oncology - Beaumont /ID# 202359, Beaumont

78240-5251

Texas Oncology - San Antonio Medical Center /ID# 202332, San Antonio

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY