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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
PrECOG, LLC.
Study ID
NCT03113422
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Induction Venetoclax — DRUG
    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.
  • Maintenance Venetoclax — DRUG
    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.

Study Details

Patients with high tumor burden, low grade follicular lymphoma that has never been treated, will receive venetoclax in combination with obinutuzumab and bendamustine. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with follicular lymphoma. Venetoclax may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether adding venetoclax to obinutuzumab and bendamustine improves the response (the tumor shrinks or disappears) in patients with follicular lymphoma. As of 9/5/2018, a higher than expected incidence of tumor lysis syndrome (TLS) was experienced among patients receiving venetoclax, obinutuzumab and bendamustine on Cycle 1, Day 1 of treatment. TLS is caused by the fast breakdown of cancer cells. These patients developed an increase in some of their blood tests (uric acid, phosphorus, potassium and/or creatinine). They received a medication called rasburicase and continued with treatment. It is unclear if the TLS was due to the venetoclax or the standard treatment of obinutuzumab and bendamustine. For the remaining patients, venetoclax will start on Cycle 2, Day 1 (previously Cycle 1, Day 1). As of 9/16/2021, additional maintenance therapy has been suspended for those patients who remain on study. These patients will not receive any further treatment and will move on to the two year survival follow-up.

Key Dates

Start date
Dec 27, 2017
Status verified
May 2025
Primary completion
May 3, 2021
Completion
Jan 6, 2023

Study Design

Enrollment
56 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Induction Venetoclax
    Cycle 1-6: Obinutuzumab intravenously (IV) and bendamustine IV. Cycle 2-6: Venetoclax (oral)
  • Experimental: Maintenance Venetoclax
    Patients with stable or improved disease will receive venetoclax by mouth daily for 24 cycles (1 cycle=1 month) and obinutuzumab IV every 2 months for 12 cycles. Patients with no evidence of disease will receive obinutuzumab IV every 2 months for 12 cycles.

Primary Outcome Measure

Complete Response (CR) at End of Induction [ Time Frame: After 6 cycles (at 28 days/cycle) of induction therapy. ]

Locations (10)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Sidney Kimmel Comprehensive Cancer Center at John HopkinsBaltimoreMaryland21205-
Mayo ClinicRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of NJNew BrunswickNew Jersey08903-
Fox ChasePhiladelphiaPennsylvania19111-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
University of VirginiaCharlottesvilleVirginia22908-
Gunderson Health System Cancer CenterLa CrosseWisconsin54601-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Atlanta, GA

By research site
Winship Cancer Institute of Emory University· Atlanta, GASidney Kimmel Comprehensive Cancer Center at John Hopkins· Baltimore, MDMayo Clinic· Rochester, MNWashington University School of Medicine· St Louis, MORutgers Cancer Institute of NJ· New Brunswick, NJFox Chase· Philadelphia, PA

Related Studies