Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

January 13, 2020

Primary Completion Date

October 20, 2022

Study Completion Date

July 26, 2024

Conditions
Mantle Cell Lymphoma
Interventions
DRUG

Venetoclax

"Cycle 1: Venetoclax by mouth daily. The dose will gradually increase during Cycle 1. (Day 1-7: 20 mg; Day 8-14: 50 mg; Day 15-21: 100 mg; Day 22-28: 200 mg.)~Cycles 2-6: Venetoclax 400 mg by mouth daily on Days 1-10 (1 cycle = 28 days)."

DRUG

Bendamustine

Cycle 1-6: Bendamustine 90 mg/m² intravenous (IV) on Days 1 and 2 of each cycle. Bendamustine may be started at 70 mg/m² in patients over the age of 75 years with comorbid conditions or patients over the age of 80 years without comorbid conditions.

DRUG

Rituximab

Cycle 1-6: Rituximab 375 mg/m² IV on Day 1 of each cycle. After 2 consecutive cycles of Rituximab IV are well tolerated, Rituximab may be given subcutaneously.

Trial Locations (7)

17033

Penn State Cancer Institute, Hershey

22903

University of Virginia Health System, Charlottesville

46202

Indiana University Simon Cancer Center, Indianapolis

48106

St. Joseph Mercy Hospital Cancer Care Center, Ann Arbor

55905

Mayo Clinic, Rochester

61801

Carle Cancer Center, Urbana

63110

Washington University School of Medicine Siteman Cancer Center, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

PrECOG, LLC.

OTHER