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PrE0403
Phase II Study of Venetoclax (ABT-199/GDC-0199) in Combination With Obinutuzumab and Bendamustine in Patients With High Tumor Burden Follicular Lymphoma as Front Line Therapy
Sponsor study identifier
Secondary identifiers
OTHER · Genentech
interventional
56
1 country
10
Study Start
December 27, 2017
Actual (reported)Primary Completion
May 3, 2021
Actual (reported)Study Completion
January 6, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 6, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 10, 2017
Actual (reported)April 13, 2017
Actual (reported)December 27, 2017
Actual (reported)May 3, 2021
Actual (reported)July 18, 2022
Actual (reported)January 6, 2023
Actual (reported)Complete Response (CR) at End of Induction
CR assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)
After 6 cycles (at 28 days/cycle) of induction therapy.
Overall Response Rate (ORR)
After 6 cycles (at 28 days/cycle) of induction therapy
Convert to CR During Maintenance Therapy (From PR in Induction)
Up to 24 cycles which corresponds to 22 months (at 28 days/cycle)
Cycle 1-6: Obinutuzumab intravenously (IV) and bendamustine IV. Cycle 2-6: Venetoclax (oral)
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.
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.
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, 21205, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Rutgers Cancer Institute of NJ
New Brunswick, New Jersey, 08903, United States
Fox Chase
Philadelphia, Pennsylvania, 19111, United States
Vanderbilt-Ingram Cancer Center
Portell CA, Jegede OA, Wagner-Johnston N, Nowakowski GS, Fletcher C, Cohen JB, Evens AM, Rosenstein LJ, Craig JW, Reddy N, Kahl BS. Phase II study of venetoclax added to bendamustine and obinutuzumab in patients with high-risk follicular lymphoma as front-line therapy: PrE0403. Blood Cancer J. 2025 May 12;15(1):93. doi: 10.1038/s41408-025-01300-1.
Craig Portell, MD
University of Virginia
56 participants (actual enrollment reported by the registry).
First Submitted
April 10, 2017
First Posted
April 13, 2017
Study Start
December 27, 2017
Actual (reported)Progression-Free Survival (PFS) in the Intent to Treat (ITT) Population.
Up to 24 months
Overall Survival (OS) in the ITT Population.
Up to 24 months
Number of Participants With Treatment-related GRADE 3+ Adverse Events as Assessed by CTCAE V4.0
Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months.
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.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Nashville, Tennessee, 37232, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Gunderson Health System Cancer Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Primary Completion
May 3, 2021
Actual (reported)Study Completion
January 6, 2023
Actual (reported)Last Updated
May 23, 2025
Results First Posted
July 18, 2022
Record last verified: 2025-05
Data is proprietary.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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