RecruitingPHASE3INTERVENTIONAL

A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)

This study, called GOLSEEK-4, is investigating a new treatment approach for follicular lymphoma. It's for people whose lymphoma has either returned (relapsed) after treatment or hasn't responded to previous therapies (refractory). The study is comparing a new medication called golcadomide, given alongside rituximab, against the usual treatments that doctors currently prescribe. The main goal is to see how well the golcadomide and rituximab combination works and if it's safe compared to existing options. This is a Phase 3 study, meaning it's one of the final stages of testing new treatments before they might become widely available.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Celgene

Enrolment target

400

Start

28 Jul 2025

Estimated completion

31 Jul 2030

Follicular Lymphoma

What is this study about?

Follicular lymphoma is a type of slow-growing cancer that affects certain white blood cells. For many people, it can come back even after treatment, or sometimes the initial treatments don't work as well as hoped. When this happens, doctors look for new and effective ways to help manage the disease.

This study is looking into a new treatment combination involving a drug called golcadomide, given together with another well-known drug called rituximab. Rituximab is already commonly used to treat follicular lymphoma. The study wants to find out if adding golcadomide to rituximab could be a better option for people whose lymphoma has either returned or hasn't responded to their previous treatments.

To do this, the study will compare this new combination against a range of other established treatments that doctors would typically consider in this situation. These standard treatments might include drugs like lenalidomide, cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone, or bendamustine. By comparing these different approaches, researchers hope to understand if the golcadomide and rituximab combination is more effective and safe.

Key takeaways

This study evaluates a new combination for follicular lymphoma.
It's for lymphoma that has returned or hasn't responded to previous treatment.
Compares golcadomide + rituximab to standard treatments.
Aims to find out if the new combination is effective and safe.
Open to adults aged 18 and over.
Patient participation helps advance understanding of lymphoma treatments.

Who may be eligible?

To join this study, your doctor would need to confirm that you have follicular lymphoma, and that it has either come back after a period of improvement or hasn't responded well to your past treatments. You would also need to have received at least one previous course of treatment that included a specific type of antibody drug (like rituximab) and a chemotherapy drug.

There are also some health checks to make sure you're well enough to take part. For example, your general health status would be checked, and specific blood tests would be done to ensure your kidney and liver are working adequately. Doctors would also need to see that your lymphoma is visible on scans.

This study is open to both men and women aged 18 and older. The study doctors will carefully review all your medical information to determine if this study is suitable for you.

Quick self-check

Do you have confirmed follicular lymphoma?
Has your lymphoma either returned or not responded to past treatments?
Have you had at least one previous treatment that included rituximab (or a similar drug) and a chemotherapy drug?
Are you generally well enough for a clinical study?
Are your blood test results (like kidney and liver function) within acceptable ranges?
Is your lymphoma visible on scans?

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

What does participation involve?

If you decide to join this study, you would receive either the new drug combination (golcadomide and rituximab) or one of the standard treatments. The decision about which treatment you receive is made randomly, like flipping a coin. You would have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how your lymphoma is responding to the treatment. These visits will help the study team understand the effects of the treatment. The total length of your participation would depend on how your treatment progresses, but there would be regular follow-up appointments.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit from a new treatment option that could be more effective than current approaches, or you might help others in the future by contributing to medical knowledge. However, there's also a chance the new treatment might not work for you, or it could have side effects. All possible side effects will be carefully explained to you by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (160)

Local Institution - 0225
Birmingham, United States· Not yet recruiting
Infirmary Cancer Care
Mobile, United States· Recruiting
Alaska Oncology and Hematology
Anchorage, United States· Recruiting
Local Institution - 0215
Little Rock, United States· Not yet recruiting
City of Hope Comprehensive Cancer Center
Duarte, United States· Recruiting
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, United States· Recruiting
Local Institution - 0008
Jacksonville, United States· Not yet recruiting
Local Institution - 0214
Tampa, United States· Not yet recruiting
Local Institution - 0217
Tampa, United States· Not yet recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, United States· Recruiting
Southeastern Regional Medical Center
Newnan, United States· Recruiting
Local Institution - 0240
Arlington Heights, United States· Not yet recruiting

+148 more sites — see the official record for the full list.

Common questions

What is follicular lymphoma?

It's a type of slow-growing cancer that affects white blood cells called lymphocytes.

What does 'relapsed/refractory' mean?

Relapsed means the lymphoma has come back after treatment. Refractory means it didn't respond well to previous treatments.

What is golcadomide?

Golcadomide is a new drug being tested in this study for follicular lymphoma.

Will I know which treatment I'm getting?

Yes, this is an 'open label' study, meaning both you and your doctor will know which treatment you are receiving.

Is this a new treatment?

The combination of golcadomide with rituximab is being studied for the first time in this patient group in this specific way.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Clinical.Trials@bms.com 8559073286 Official trial record

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