Ofatumumab In Older Patients With Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas
Status:
Withdrawn
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
Summary
This research study will only include two types of non-Hodgkin Lymphoma (NHL), follicular
lymphoma or marginal zone lymphoma and participants will be age 70 or older.
The purpose of this research study is to learn about the safety of the treatment with the
drug ofatumumab to find out what effects, both good and bad this treatment has on lymphoma.
Ofatumumab is a monoclonal antibody. Monoclonal antibodies are being used to treat some types
of cancer. Monoclonal antibodies are a type of protein made in a laboratory that can bind
substances in the body including cancer cells. Ofatumumab binds to the protein called CD20,
which is found on B-cells and lymphoma cells.
The study drug, Ofatumumab, is approved by the United States Food and Drug Administration
(FDA) for treatment of other types of blood cancer and is not approved for use in patients
with non-Hodgkin Lymphoma. The use of ofatumumab in this study is considered investigational.
In addition to learning about ofatumumab, the researchers are interested in learning about
how this cancer treatment affects daily activities. Participants will be asked to complete a
Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional
status, mental health, and level of social support. This assessment will help the health care
team understand a participant's "functional age" as compared to a participant's actual age.
The researchers also want to collect blood samples to study molecules in follicular lymphoma
cells called 'biomarkers' to learn about how the lymphoma responds to therapy. A biomarker is
a molecule (for example, DNA or protein) found in the blood or tissues that is a marker for
disease. In this study, the investigators will measure the changes of the biomarker called
bcl-2. This biomarker research will only be in subjects with follicular lymphoma.