NCT03198026

Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas

Phase II, Single Arm, Open Label Multi-center Study of Obinutuzumab and Ibrutinib in the Front Line Treatment of Indolent Non-Hodgkin's Lymphomas

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well obinutuzumab and ibrutinib work as front line therapy in treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab and ibrutinib may work better in treating patients with non-Hodgkin's lymphomas.

Detailed description

PRIMARY OBJECTIVES: I. To assess the efficacy of the combination of ibrutinib and obinutuzumab in chemotherapy naive patients with indolent lymphomas. SECONDARY OBJECTIVES: I. To assess progression free survival rates and overall survival rates in indolent lymphomas. II. To assess safety and tolerability of the combination. III. To evaluate response using positron emission tomography (PET) and correlate PET negativity with durability of response. OUTLINE: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses. After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then 1 year later.

Conditions

• Non-Hodgkin's Lymphoma
• Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
• Ann Arbor Stage II Follicular Lymphoma
• Ann Arbor Stage II Nodal Marginal Zone Lymphoma
• Ann Abor Stage III B-Cell Non-Hodgkin Lymphoma
• Ann Arbor Stage III Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
• Ann Arbor Stage III Follicular Lymphoma
• Ann Arbor Stage III Nodal Marginal Zone Lymphoma
• Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma
• Ann Arbor Stage IV Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
• Ann Arbor Stage IV Follicular Lymphoma
• Ann Arbor Stage IV Nodal Marginal Zone Lymphoma
• Grade 1 Follicular Lymphoma
• Grade 2 Follicular Lymphoma
• Grade 3a Follicular Lymphoma
• Indolent Non-hodgkin Lymphoma
• Stage II Splenic Marginal Zone Lymphoma
• Stage III Splenic Marginal Zone Lymphoma
• Stage IV Splenic Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
BIOLOGICAL	Obinutuzumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2018-02-20
• Primary completion: 2026-09-11
• Completion: 2032-02-20
• First posted: 2017-06-23
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study