Ofatumumab In Older Patients With 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.
Lymphoma, B-Cell, Marginal Zone
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Of Ofatumumab In Older (≥70 Years) Patients With Previously Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas|
- To determine overall response rates (ORR) following ofatumumab treatment in older (≥ 70 years old) patients with previously untreated low or intermediate risk indolent NHL [ Time Frame: 2 years ] [ Designated as safety issue: No ]The ORR will be evaluated as the rate of complete responses (CR) + partial responses (PR) as defined by the Revised Response Criteria for Malignant Lymphoma (RRCML)
- To determine the complete response rate (CR) following ofatumumab treatment in older patients without prior systemic therapy for low or intermediate risk indolent NHL [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To evaluate the toxicity and tolerability of ofatumumab treatment in the study population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Estimate progression free survival (PFS) at 2 years after ofatumumab treatment [ Time Frame: 4 years ] [ Designated as safety issue: No ]PFS is defined as the time from study entry until lymphoma progression or death as a result of any cause.
- Evaluate molecular response to ofatumumab therapy by performing PCR analysis for BCL2/IgH from the peripheral blood at baseline and 3 months from initiation of treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]Molecular response is defined as the percentage of patients with detectable BCL2 PCR at baseline who convert from BCL2 PCR-detectable to undetectable disease status in the peripheral blood.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Intravenous; Dosage: 1000mg; Frequency: one time per week; Duration: 8 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263418
|Principal Investigator:||Steven Park, MD||UNC Lineberger Comprehensive Cancer Center|