The BRIGHT study is a clinical trial evaluating the safety and effectiveness of an investigational medication for advanced indolent (low-grade) non-Hodgkin’s lymphoma and mantle cell lymphoma in patients who have not yet received treatment.
What should I know about the investigational medication?
What are the risks and benefits of study participation?
What medical tests and evaluations are involved?
What study treatment will I receive?
How long is study participation?
Who has access to my personal information from the study?
What happens at the end of the research study?
Whom should I contact if I have more questions?
The investigational medication being evaluated in this study is called bendamustine hydrochloride. It has been approved by the U.S. Food and Drug Administration (FDA) for treating patients with:
The following serious adverse reactions have been associated with bendamustine hydrochloride in clinical trials:
Because bendamustine hydrochloride is not currently approved for the treatment of newly diagnosed advanced indolent NHL or mantle cell lymphoma, it is considered investigational for the purposes of the BRIGHT study.
Researchers are now conducting research with this investigational combination therapy
(rituximab and bendamustine hydrochloride) to evaluate whether it will be an effective first-line treatment option for both advanced indolent non-Hodgkin’s lymphoma and mantle cell lymphoma patients.
As a medical research study participant, you may contribute to new treatment research that could help others with advanced indolent non-Hodgkin’s lymphoma and mantle cell lymphoma. However, as with any medical research study, there are potential risks. It is possible that your condition could become worse or you could experience a side effect. It could be a common, known side effect such as headache, shortness of breath, dizziness, or nausea, or it could be a side effect that has not been seen before. The following serious adverse reactions have been associated with bendamustine hydrochloride in clinical trials:
The most common hematologic abnormalities (frequency ≥15%) were:
The most common non-hematologic adverse reactions (frequency ≥15%) were nausea, fatigue, vomiting, diarrhea, pyrexia (fever), constipation, anorexia (loss of appetite), cough, headache, weight decreased, dyspnea (shortness of breath), rash, and stomatitis (inflammation or blistering of the mouth, including canker sores).
Your study doctor will describe the risks associated with this study in more detail prior to your study entry. In addition, you will be provided with an informed consent form (ICF) that you must sign before you begin your participation. This ICF provides all study-related details, including risks and benefits.
You may benefit from participating in the BRIGHT study, but this cannot be guaranteed. Possible benefits of study participation include having access to investigational treatments before they are widely available and helping others by contributing to the development of new therapies. At a minimum, you will have access to medical care options and diagnostic tools used in the treatment of advanced indolent non-Hodgkin’s lymphoma and mantle cell lymphoma.
Study participants will be monitored by the study staff during the study, and will be asked to visit the clinic so the study staff can check on their safety and progress. At these clinic visits, you will undergo a series of medical exams and evaluations, including, but not limited to:
Most medical research studies divide participants into study groups. One group often receives the investigational medication, while the other may receive a standard treatment.
At the beginning of the BRIGHT study, you will be randomly assigned (like the flip of a coin, or chosen by chance) to one of two treatment groups. You will have a 50% chance of being assigned into either one of these two treatment groups. No matter which treatment group you are placed, the level of attention and medical care you receive from the study staff will be the same.
The two treatment groups in the BRIGHT study are:
This study is an open-label study, which means that participants will know which treatment they are receiving.
At a minimum, your participation could last about three and a half years, which includes:
Every effort will be made to protect the confidentiality of your information. Some people will require access to your data, including:
Results of the study may be published in scientific journals or presented at medical meetings, but your identity will remain confidential.
While the BRIGHT study is being conducted, researchers will review the information collected during the study to determine the investigational medication’s effectiveness and safety.
Researchers can submit the study results to medical journals and they must submit data to the FDA. The information from the trial may add to the prescribing information of the product.