Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy
Completed · Phase 2
Conditions studied: Follicular Lymphoma, Non-Hodgkin's Lymphoma Follicular, Non-Hodgkin's Lymphoma, Adult High Grade
In brief
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 facts
- Study ID
- NCT03113422
- Run by
- PrECOG, LLC.
- People needed
- 56
- Starts
- 2017-12-27
- Expected to finish
- 2023-01-06
- Last updated by the study team
- 2025-05-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
- Sidney Kimmel Comprehensive Cancer Center at John Hopkins — Baltimore, Maryland, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Rutgers Cancer Institute of NJ — New Brunswick, New Jersey, United States
- Fox Chase — Philadelphia, Pennsylvania, United States
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
- University of Virginia — Charlottesville, Virginia, United States
- Gunderson Health System Cancer Center — La Crosse, Wisconsin, United States
- University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.