NCT02736617

Obinutuzumab in Combination With Ibrutinib in Treating Patients With Relapsed Mantle Cell Lymphoma

A Phase II Study of Obinutuzumab (GA-101) in Combination With Ibrutinib (I) for the Treatment of Relapsed Mantle Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well obinutuzumab works in combination with ibrutinib in treating patients with mantle cell lymphoma that has returned (relapsed) or that does not respond to treatment (refractory). Obinutuzumab binds to a protein called cluster of differentiation (CD)20, which is found on B cells and some types of leukemia and lymphoma cells and help the immune system kill cancer cells. Ibrutinib blocks a protein called Bruton's tyrosine kinase (BTK), which may help keep cancer cells from growing. Giving obinutuzumab in combination with ibrutinib may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVE: I. Best overall response of complete response/partial response (CR/PR). SECONDARY OBJECTIVES: I. Toxicity defined as any adverse event (AE) grade 3 and higher. II. Progression free survival. EXPLORATORY/CORRELATIVE OBJECTIVES: I. Gene expression profiling using Lymph5Cx test. II. Sequencing using the ion torrent platform (76 gene panel for known mutations in lymphoma). III. Sequencing of BTK and phospholipase-C gamma (PLC) to evaluate for mutations. IV. Minimal residual disease testing (MRD by flow cytometry and targeted sequencing post treatment). OUTLINE: Patients receive obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving partial response (PR) continue to receive obinutuzumab IV every 2 months and ibrutinib PO QD for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years.

Conditions

• Recurrent Mantle Cell Lymphoma
• Refractory Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
BIOLOGICAL	Obinutuzumab	Given IV

Timeline

• Start date: 2016-07-05
• Primary completion: 2021-06-02
• Completion: 2021-06-02
• First posted: 2016-04-13
• Last updated: 2022-01-05
• Results posted: 2022-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study