NCT01729806

Ipilimumab and Rituximab in Treating Patients With Relapsed or Refractory B-cell Lymphoma

A Phase I Study of Ipilimumab in Combination With Rituximab in Patients With Relapsed/Refractory CD20+ B-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This partially randomized phase I trial studies the side effects and best dose of ipilimumab when given together with rituximab in treating patients with B-cell lymphoma that has returned or has not responded to treatment. Monoclonal antibodies, such as ipilimumab and rituximab, may interfere with the ability of cancer cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. To determine a recommended phase II dose for ipilimumab in combination with rituximab. SECONDARY OBJECTIVES: I. To obtain preliminary information on the effect of adding ipilimumab to rituximab in regard to: immune response; clinical anti-tumor response/overall remission rate (ORR) (complete remission + partial remission); progression free survival (PFS). OUTLINE: This is a dose-escalation study of ipilimumab followed by a randomized study. PART I: INDUCTION: Patients receive ipilimumab intravenously (IV) over 90 minutes once every 3 weeks for 12 weeks and rituximab IV over 2-6 hours once weekly for 4 weeks. MAINTENANCE: Patients receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year. PART II: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab IV over 90 minutes once weekly in weeks 1, 4, 7, and 10. Patients then receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab IV over 90 minutes once weekly in weeks 3, 6, 9, and 12. Patients then receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 12 months.

Conditions

• CD20 Positive
• Recurrent B-Cell Non-Hodgkin Lymphoma
• Refractory B-Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Ipilimumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Rituximab	Given IV

Timeline

• Start date: 2012-11-19
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2012-11-20
• Last updated: 2018-04-11

Locations

7 sites across 1 country: United States