RecruitingPHASE3INTERVENTIONAL

A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma

This research is looking at a new medicine called odronextamab for adults with a type of cancer called follicular lymphoma, which hasn't been treated before. The study has two main parts. The first part will check how safe the new drug is when given on its own and if people can tolerate it well. The second part will compare odronextamab to existing standard treatments, which include rituximab combined with different chemotherapy drugs. The researchers also want to understand any side effects, how much of the drug stays in the blood, if the body develops a reaction to the drug, and how it might affect a person's daily life and overall well-being.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Regeneron Pharmaceuticals

Enrolment target

822

Start

12 Dec 2023

Estimated completion

03 Nov 2029

Follicular Lymphoma (FL)

What is this study about?

This clinical trial is designed to investigate a new drug called odronextamab for adults who have a specific type of cancer called follicular lymphoma. This is a form of non-Hodgkin lymphoma (NHL), and this study focuses on patients whose follicular lymphoma has not been treated with medication before. The main goal is to see if this new drug is a good option for treating this condition.

The study is split into two main sections. In the first part, researchers will give odronextamab on its own to a small group of people. This helps them understand if the drug is safe and if patients can handle its side effects. In the second part, they will compare odronextamab to the treatments currently used for follicular lymphoma. These standard treatments usually involve a drug called rituximab given alongside different types of chemotherapy medicines. By doing this comparison, the researchers hope to learn if odronextamab works better, the same, or not as well as what doctors currently prescribe.

Beyond simply comparing the treatments, the study is also looking into several other important questions. For example, they want to find out what kind of side effects people might experience, how the drug acts in the body (like how much is in the blood at different times), and if the body's immune system tries to fight off the drug, which could make it less effective. Importantly, the study will also look at how taking this new drug might affect a person's everyday life and their overall quality of life.

Key takeaways

This study evaluates a new drug, odronextamab, for previously untreated follicular lymphoma.
It aims to check the safety and how well odronextamab works compared to current standard treatments.
Participation involves regular visits, tests, and closely monitoring your health and side effects.
You might receive the new drug or standard treatment, determined by chance in one part of the study.
Your quality of life and daily activities will be monitored as part of the research.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, adults must have a specific diagnosis of follicular lymphoma (grades 1 to 3a) that has spread to certain parts of the body (stage II bulky, stage III, or stage IV) and requires treatment. Doctors will need to see clear signs of the disease on scans like CT or MRI. Patients should also be generally well enough to take part, meaning they can manage most daily activities without too much difficulty, and their organs like bone marrow and liver are working properly.

However, some people would not be able to join. This includes those whose lymphoma is affecting their brain or spinal cord, or if their cancer has changed into a more aggressive type. People with certain other types of blood cancers, such as Waldenstrom's macroglobulinemia, are also not eligible. You also can't have received any previous treatment for your lymphoma with medication, and you shouldn't have any serious infections or allergies to the study drugs.

It's important to remember that there are other specific guidelines set out by the study doctors that fully determine who can or cannot take part. Your doctor can discuss these with you in detail.

Quick self-check

Are you an adult aged 18 or over?
Have you been diagnosed with follicular lymphoma (grades 1-3a) that needs treatment?
Have you NOT received any drug treatment for your follicular lymphoma before?
Do you feel generally well enough to go about most of your daily activities?
Have scans (like CT or MRI) shown clear signs of your lymphoma?
Do you NOT have lymphoma affecting your brain or spinal cord, or certain other types of blood cancers?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first undergo various tests and checks to make sure the study treatments are right for you. If eligible, you would likely receive either the new drug odronextamab or a combination of rituximab and chemotherapy, depending on which part of the study you are in. These treatments would be given at the hospital or clinic over a period of time, and you would have regular appointments for blood tests, scans, and physical examinations to see how you're responding and to monitor any side effects.

The study team will track how you are feeling and how well you are managing your daily activities throughout the treatment period. After your main treatment phase, there will be a follow-up period where doctors will continue to monitor your health. The total time you would be involved in the study, including treatment and follow-up, would depend on the specific study plan and your individual response, but clinical trials often involve several months to a few years of participation.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new treatment like odronextamab that isn't yet widely available, which could be more effective than current options for your follicular lymphoma. However, there are also potential risks, including side effects from the study drugs, which can vary from mild to severe, or the possibility that the new treatment might not work as well as expected. All known risks will be carefully explained to you, and your health will be closely monitored throughout the study. Remember, your participation is completely voluntary; you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (190)

University of Arizona Cancer Center
Tucson, United States· Recruiting
David Geffen School of Medicine at UCLA
Los Angeles, United States· Recruiting
UC Irvine Health
Orange, United States· Withdrawn
Investigative Clinical Research of Indiana
Noblesville, United States· Recruiting
Beth Israel Deaconess Medical Center
Boston, United States· Recruiting
Karmanos Cancer Institute
Detroit, United States· Recruiting
Hattiesburg Clinic
Hattiesburg, United States· Completed
Icahn School of Medicine at Mt Sinai
New York, United States· Recruiting
Stony Brook University Hospital
Stony Brook, United States· Recruiting
Clinical Research Alliance Inc
Westbury, United States· Withdrawn
University of North Carolina
Chapel Hill, United States· Recruiting
Levine Cancer Institute
Charlotte, United States· Recruiting

+178 more sites — see the official record for the full list.

Common questions

What is follicular lymphoma?

Follicular lymphoma is a slowly growing type of cancer that affects a specific type of white blood cell called lymphocytes. It's a common form of non-Hodgkin lymphoma.

What is 'standard of care' treatment?

'Standard of care' refers to the best medical treatments currently known and widely accepted by doctors for a particular condition.

Will I definitely get the new drug?

Not necessarily. In the second part of the study, people are assigned by chance (like flipping a coin) to either receive the new drug or the standard treatment.

What does 'previously untreated' mean?

It means you have not had any medical treatments like chemotherapy or other drug therapies for your follicular lymphoma before enrolling in this study.

Will this study affect my quality of life?

The study aims to understand exactly that. Researchers will ask questions and collect information about how the treatments impact your daily activities and how you feel overall.

How to find out more

Clinical Trials Administrator

clinicaltrials@regeneron.com 844-734-6643 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.