Ofatumumab In Older Patients With Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas (NCT01263418) | Clinical Trial Compass
WithdrawnPhase 2
Ofatumumab In Older Patients With Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas
Stopped: No patients enrolled and funding has been withdrawn.
0Started 2011-06
Plain-language 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.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Stage II, III, or IV follicular or marginal zone B-cell CD20+ lymphomas not previously treated with systemic therapy
* Low/intermediate risk grade 1 or 2 follicular NHL or marginal zone lymphoma defined by 2004 Follicular Lymphoma International Prognostic Index (FLIPI) scores
* Measurable disease as assessed by 2 dimensional measurement by CT and/or by bone marrow histopathology.
* Age ≥ 70 years at time of informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Life expectancy of at least 3 months
* Documented negative serologic testing for human immunodeficiency virus (HIV)
* Documented negative serologic testing for Hepatitis B (HB); this is defined as negative for HBsAg;
* If negative for HBsAg but HBcAb positive (regardless of HBsAb status), an hepatitis B virus (HBV) DNA test will be performed and must be negative for eligibility. Those with negative HBV DNA may be included but must undergo HBV DNA PCR testing every 2 months (see Time and Events table). Prophylactic antiviral therapy may be initiated at the discretion of the investigator in these patients.
* Adequate bone marrow function (without transfusion support within four weeks of screening) as demonstrated by:
* Hemoglobin ≥ 8 g/dL
* Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
* Platelet count ≥ 50,000/mm3
* Adequate hepatic and renal function as demonstrated by:
* Aspartate aminotransferase (AST/ALT) ≤ 2.5 × upper limit of normal (ULN)
* T…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine overall response rates (ORR) following ofatumumab treatment in older (≥ 70 years old) patients with previously untreated low or intermediate risk indolent NHL