Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

December 27, 2017

Primary Completion Date

May 3, 2021

Study Completion Date

January 6, 2023

Conditions
Follicular LymphomaNon-Hodgkin's Lymphoma FollicularNon-Hodgkin's Lymphoma, Adult High Grade
Interventions
DRUG

Induction Venetoclax

"1 cycle = 28 days.~* Cycle 1-6: Obinutuzumab IV. Cycle 1, Day 1 obinutuzumab 100 mg and Cycle 1, Day 2 obinutuzumab 900 mg for total dose of 1000 mg. On Cycle 1, Day 8 and Day 15 obinutuzumab 1000 mg. Starting with Cycle 2, obinutuzumab 1000 mg on Day 1 only of each cycle.~* Cycle 1-6: Bendamustine 90 mg/m² IV on Days 1 and 2 of each cycle over 15 minutes after obinutuzumab.~* Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10 administered before obinutuzumab and/or bendamustine."

DRUG

Maintenance Venetoclax

Patients whose disease is the same or improved will receive venetoclax 800 mg by mouth daily for 24 cycles (1 cycle=1 month) and obinutuzumab 1000 mg IV every 2 months for 12 cycles. Patients with no evidence of disease will receive obinutuzumab 1000 mg IV every 2 months for 12 cycles.

Trial Locations (10)

19111

Fox Chase, Philadelphia

21205

Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore

22908

University of Virginia, Charlottesville

30322

Winship Cancer Institute of Emory University, Atlanta

37232

Vanderbilt-Ingram Cancer Center, Nashville

53792

University of Wisconsin, Madison

54601

Gunderson Health System Cancer Center, La Crosse

55905

Mayo Clinic, Rochester

63110

Washington University School of Medicine, St Louis

08903

Rutgers Cancer Institute of NJ, New Brunswick

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

PrECOG, LLC.

OTHER