About the BRIGHT medical research study

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?

What should I know about the investigational medication?

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:

Indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen
Chronic lymphocytic leukemia (CLL); efficacy relative to first-line therapies other than chlorambucil has not been established

The following serious adverse reactions have been associated with bendamustine hydrochloride in clinical trials:

Myelosuppression/bone marrow suppression (a decrease in the production of blood cells);
Infections;
Infusion reactions and anaphylaxis (a severe allergic reaction);
Tumor lysis syndrome (a rapid killing of the tumor cells generating so many break-down products of the dying cells that the kidney is prevented from working correctly);
Skin reactions; and
Other malignancies.

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.

What are the risks and benefits of study participation?

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:

Myelosuppression/bone marrow suppression (a decrease in the production of blood cells);
Infections;
Infusion reactions and anaphylaxis (a severe allergic reaction);
Tumor lysis syndrome (a rapid killing of the tumor cells generating so many break-down products of the dying cells that the kidney is prevented from working correctly);
Skin reactions; and
Other malignancies.

The most common hematologic abnormalities (frequency ≥15%) were:

Lymphopenia, leukopenia, and neutropenia, conditions involving lower than normal counts of certain types of white blood cells (cells that help your body fight infections) in the blood;
Anemia, a condition involving a decrease in the number of healthy red blood cells; and
Thrombocytopenia, a condition involving low levels of platelets in the blood.

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.

What medical tests and evaluations are involved?

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:

Physical exams
Vital sign measurements
- temperature
- heart rate
- blood pressure
blood and urine samples
Questions about your medical history, any medications you're taking, and your general health
Tumor biopsies, which may include
- CT or MRI scan
- PET scan
- bone marrow biopsy/aspirate
MUGA or ECHO scans to determine the function of your heart
Quality of life assessments
Questions about side effects/bad outcomes
Electrocardiogram, a test to measure the activity of your heart
Pregnancy test
- for women of child-bearing potential
- women who are pregnant or breast-feeding will not be allowed to participate in this study

What study treatment will I receive?

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:

Group 1—participants will receive the investigational drug (bendamustine hydrochloride) in combination with a standard treatment (rituximab)
Group 2—participants will receive standard chemotherapy treatment with one of two treatment combinations (R-CHOP or R-CVP)

This study is an open-label study, which means that participants will know which treatment they are receiving.

How long is study participation?

At a minimum, your participation could last about three and a half years, which includes:

30-day screening period to determine final eligibility
Five to eight month treatment period receiving either the investigational treatment or standard treatment
At minimum, a three-year follow-up period to review your progress

Who has access to my personal information from the study?

Every effort will be made to protect the confidentiality of your information. Some people will require access to your data, including:

the company sponsoring this research
representatives of the study sponsor (including contract research organizations hired to help with the study)
the laboratories processing your blood and urine samples and other diagnostic data
regulatory agencies, such as:
- the U.S. Food and Drug Administration (FDA)
- the federal Office for Human Research Protections (OHRP)
- Health Canada
- other international regulatory authorities
institutional review boards (IRBs)

Results of the study may be published in scientific journals or presented at medical meetings, but your identity will remain confidential.

What happens at the end of the research study?

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.

Whom should I contact if I have any more questions?

Contact your local study clinic if you have any additional questions.
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