Stage IV Diffuse Large B-Cell Lymphoma Clinical Trial
Official title:
Phase II Study of Pidilizumab (MDV9300) in Patients With Diffuse Large B-Cell Lymphoma Following First Remission
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.
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.
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