Lymphoma, Non-Hodgkin Clinical Trial
Official title:
A Phase II Trial Of Ofatumumab In Older (≥70 Years) Patients With Previously Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas
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.
This multicenter Phase II clinical study will investigate the overall response rate (ORR)
after 2 months of therapy with weekly ofatumumab in older (≥70 years of age) patients with
previously untreated low or intermediate risk indolent NHL (n=37). Secondary objectives
include progression free survival (PFS) at 2 years, and an evaluation of the toxicity and
tolerability of ofatumumab in this population.
We will also evaluate molecular response to ofatumumab by performing PCR analysis for
BCL2/IgH from the peripheral blood.
We will conduct an exploratory analysis of the minimum observed serum concentration (Cmin)
of ofatumumab prior to the last dose and correlate this level with ORR.
This trial includes administration of a Geriatric Assessment (GA) tool which patients will
be asked to complete serially during the trial.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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