A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT02187861
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax will be administered as per the schedule specified under arm description.
  • Bendamustine — DRUG
    Bendamustine will be administered as per the schedule specified under arm description.
  • Rituximab — DRUG
    Rituximab will be administered as per the schedule specified under arm description.

Study Details

This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.

Key Dates

Start date
Dec 1, 2014
Status verified
Jun 2019
Primary completion
Sep 27, 2016
Completion
Mar 16, 2018

Study Design

Enrollment
163 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)
    Participants will receive venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in will continue until first 9 participants complete the safety observation window of 28 days. Participants will continue receiving the same treatment as decided for Arm B.
  • Experimental: Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)
    Participants will receive venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle will be of 28 days.
  • Experimental: Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
    Participants will receive venetoclax at doses decided from safety run-in orally once daily continuously for 1 year along with rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
  • Active Comparator: Chemotherapy-Containing Cohort: Arm C (BR)
    Participants will receive rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.

Primary Outcome Measure

Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA) [ Time Frame: 6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days) ]

Locations (17)

FacilityCityStateZIPSite coordinators
Southern Cancer Center, PCMobileAlabama36608-
Arizona Cancer CenterTucsonArizona85719-
UCLA School of Medicine; Hematology/OncologyLos AngelesCalifornia90095-
Nothwest Georgia Oncology Centers P.CAustellGeorgia30106-
Northwestern UniversityChicagoIllinois60611-
University of Illinois at Chicago College of MedicineChicagoIllinois60612-7302-
Primary Healthcare Associates SC - HarveyHarveyIllinois60426-
University of Kansas; Medical Center & Medical pavilionWestwoodKansas66205-
Sidney Kimmel Comp Cancer CtrBaltimoreMaryland21231-1000-
Hackensack University Medical CenterHackensackNew Jersey07601-
James P. Wilmot Cancer CenterRochesterNew York14642-
University of Pennsylvania; School of MedicinePhiladelphiaPennsylvania19104-
Allegheny General HospitalPittsburghPennsylvania15212-
University of PittsburghPittsburghPennsylvania15213-
University of VirginiaCharlottesvilleVirginia22903-
VCU Massey Cancer CenterRichmondVirginia23298-003-
West Virginia Uni Med. Center - Robert Byrd Health ScienceMorgantownWest Virginia26506-

Find similar trials in Mobile, AL

By research site
Southern Cancer Center, PC· Mobile, ALArizona Cancer Center· Tucson, AZUCLA School of Medicine; Hematology/Oncology· Los Angeles, CANothwest Georgia Oncology Centers P.C· Austell, GANorthwestern University· Chicago, ILUniversity of Illinois at Chicago College of Medicine· Chicago, IL

Related Studies