NCT02530125

Pidilizumab in Treating Patients With Stage III-IV Diffuse Large B-Cell Lymphoma Following First Remission

Phase II Study of Pidilizumab (MDV9300) in Patients With Diffuse Large B-Cell Lymphoma Following First Remission

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate pidilizumab and its effect, bad and/or good, on the immune system in relation to its ability to fight cancer cells. Many cancers can be brought to a phase called complete remission (no cancer is found) but have a chance that they may come back. Researchers are working to improve therapy and to find new drugs that lower the chance of disease coming back. This study uses a drug called pidilizumab. The drug targets our immune system. It can change how our immune system finds cancer cells. The drug may kill any remaining cancer cells that we cannot see with computed tomography (CT) scans. The drug, pidilizumab, is being studied in other cancers.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the rate of response, whereby either cluster of differentiation (CD)4+CD25+programmed death 1 ligand 1 (PD-L1)+ T lymphocytes or CD4+CD62L+CD127+ T lymphocytes has an "increase" following administration of pidilizumab in patients with diffuse large B-cell lymphoma (DLBCL) that have completed induction chemotherapy. SECONDARY OBJECTIVES: I. To determine the toxicity and tolerability of pidilizumab therapy following induction chemotherapy. II. To estimate the progression free survival (PFS) at 2 years. III. To estimate the overall survival (OS) at 2 years. IV. To estimate time to second line chemotherapy (TSLC) at 2 years. TERTIARY OBJECTIVES: I. To characterize programmed death 1 (PD-1) pathway specific expression markers from the diagnostic biopsy specimens. II. To characterize serum biomarkers of immune and inflammatory response during treatment with pidilizumab. III. To characterize levels of soluble PD-L1 related to treatment with pidilizumab. OUTLINE: Patients receive pidilizumab intravenously (IV) over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity. After completion of treatment, patients are followed up at 30 days and then every 3 months for 2 years.

Conditions

• Stage III Diffuse Large B-Cell Lymphoma
• Stage IV Diffuse Large B-Cell Lymphoma

Interventions

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

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-08-20
• Last updated: 2018-03-19
• Results posted: 2018-03-19

Locations

2 sites across 1 country: United States