NCT04450173

Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma

A Phase II Trial of the Combination of Obinutuzumab, Ibrutinib, and Venetoclax in Patients With Previously Untreated Follicular Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well obinutuzumab, ibrutinib, and venetoclax work in treating patients with previously untreated stage II-IV follicular lymphoma. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Ibrutinib and venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab, ibrutinib, and venetoclax together may work better in treating follicular lymphoma compared to each drug alone.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the efficacy of obinutuzumab combined with venetoclax and ibrutinib in patients with previously untreated follicular lymphoma (FL) (determined by a positron emission tomography \[PET\]/computed tomography \[CT\] complete response \[CR\] rate at 12 months as per International Workshop Lymphoma Response Criteria, Cheson 2014). SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of obinutuzumab in combination with venetoclax and ibrutinib in patients with untreated FL as assessed by frequency, severity, and relatedness of treatment-emergent adverse events (AEs) as well as frequency of treatment-emergent AEs requiring discontinuation or dose reduction of study drug. II. To evaluate the efficacy of obinutuzumab in combination with venetoclax and ibrutinib in subjects with untreated FL as assessed by CR at 30 months, overall response rate (ORR) (CR + partial response \[PR\]), duration of response (DOR), time to next anti-lymphoma treatment (TTNT), progression-free survival (PFS), and OS. OUTLINE: Patients receive obinutuzumab intravenously (IV) over 60 minutes on days 1, 8, and 15 of cycle 1, day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, and 24. Patients also receive venetoclax orally (PO) once daily (QD) on days 1-28 (days 4-28 of cycle 1) and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 2 years.

Conditions

• Ann Arbor Stage II Follicular Lymphoma
• Ann Arbor Stage III Follicular Lymphoma
• Ann Arbor Stage IV Follicular Lymphoma
• Grade 1 Follicular Lymphoma
• Grade 2 Follicular Lymphoma
• Grade 3a Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
BIOLOGICAL	Obinutuzumab	Given IV
DRUG	Venetoclax	Given PO

Timeline

• Start date: 2021-02-24
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2020-06-29
• Last updated: 2026-04-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study