Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

This study is investigating a new medication called golcadomide when given alongside rituximab, a common treatment for a type of cancer called follicular lymphoma. We are focusing on patients who have recently been diagnosed with advanced follicular lymphoma and haven't had treatment for it yet. The main goals are to find out how effective this new drug combination is at treating the lymphoma and to understand any side effects it might cause. By doing this, we hope to learn if this new approach could be a helpful option for people living with follicular lymphoma in the future. Your involvement could help us understand more about this potential new therapy.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Celgene

Enrolment target

Start

30 Aug 2024

Estimated completion

27 Nov 2028

Lymphoma, Follicular

What is this study about?

This study is about a type of cancer called follicular lymphoma. If you or someone you know has recently been told they have follicular lymphoma that is considered advanced, this study might be for you. We are looking at a new medication called golcadomide, which we're giving together with a standard treatment called rituximab. Rituximab is already used to treat follicular lymphoma, and we want to see if adding golcadomide makes the treatment even better.

The main aim is to understand two important things: first, how well this new combination works in treating follicular lymphoma. This means looking at if it can shrink the lymphoma or stop it from growing. Second, we want to know if this combination is safe. We'll be carefully watching for any side effects or problems that might happen during the treatment.

By taking part, you would be helping doctors and researchers learn more about new ways to treat follicular lymphoma. This research is a step towards finding potentially more effective and safer treatments for people with this condition in the future.

Key takeaways

This study is for newly diagnosed advanced follicular lymphoma.
It tests a new drug, golcadomide, combined with standard treatment.
The aim is to check how well the treatment works and if it's safe.
You would receive regular medical check-ups and treatment at a clinic.
Participation is voluntary, and you can withdraw at any time.
Your involvement could help improve future treatments for others.

Who may be eligible?

To join this study, you must have been diagnosed with a specific type of follicular lymphoma (grades 1, 2, or 3a) and it needs to be an advanced stage (Stage II to IV). This means the lymphoma is affecting wider areas of your body, but you shouldn't have had any prior treatment for it, like chemotherapy or radiotherapy, other than for very early, localised disease. We would also need to have a recent sample of your lymphoma tissue to confirm the diagnosis.

Your doctor will need to agree that you should start treatment for your lymphoma. This could be because your tumour is quite large (over 7cm, or spread to several areas over 3cm each), you have bothersome symptoms like fevers, night sweats, or significant weight loss, or if the lymphoma is causing issues like low blood counts or fluid build-up.

You would not be able to join this study if your lymphoma has changed into a more aggressive type, or if you have grade 3b follicular lymphoma. Also, if you have any other serious medical conditions, infections, or mental health problems that might make taking part difficult or unsafe, then you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with follicular lymphoma (grades 1, 2, or 3a)?
Has my doctor said my lymphoma is an advanced stage (Stage II-IV)?
Have I NOT had any treatment for my follicular lymphoma yet (except for early stage, localised disease)?
Have I discussed with my doctor that I need treatment for my lymphoma?
Am I at least 18 years old?
Do I understand that I cannot join if my lymphoma is a more aggressive type (grade 3b or transformed)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medications: golcadomide and rituximab. Depending on your situation, you might also receive other standard chemotherapy drugs like cyclophosphamide, doxorubicin, vincristine, and prednisone, or bendamustine. You would have regular visits to the clinic for medical checks, blood tests, and to receive your treatment. These visits are important so the research team can monitor your health, how well the treatment is working, and if you have any side effects. The exact schedule of visits and treatments would be explained to you in detail by the study team. You would be followed up for a period after your main treatment ends to see how you are doing in the longer term. The total duration of your participation, including follow-up, will be clearly outlined by the study team.

Potential risks and benefits

Taking part in any clinical study has potential benefits and potential risks. A possible benefit of joining this study is that you might receive a new treatment combination that could be more effective for your follicular lymphoma than standard options. However, as golcadomide is a new drug in this combination, there's always a chance it might not work as expected, or it could cause side effects that we don't fully know about yet. You might experience side effects from any of the drugs used in the study, and some of these could be serious. The research team will explain all known side effects before you decide to join. It's very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (56)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 0152
Verified postcode
Birmingham, United States
Local Institution - 0055
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Anchorage, United States
Local Institution - 0180
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Phoenix, United States
Local Institution - 0190
Verified postcode
Tucson, United States
Local Institution - 0035
Verified postcode
San Francisco, United States
Local Institution - 0022
Verified postcode
Washington D.C., United States
Local Institution - 0209
Verified postcode
Fort Myers, United States
Local Institution - 0005
Verified postcode
Jacksonville, United States
Local Institution - 0210
Verified postcode
St. Petersburg, United States
Local Institution - 0026
Verified postcode
Tampa, United States
Local Institution - 0208
Verified postcode
West Palm Beach, United States
Local Institution - 0019
Verified postcode
Westwood, United States

Common questions

What is follicular lymphoma?

Follicular lymphoma is a slow-growing type of cancer that affects a certain kind of white blood cell called lymphocytes. It's one of the more common types of non-Hodgkin lymphoma.

What does 'advanced stage' mean?

'Advanced stage' means the lymphoma has spread to several different areas of your body, rather than being in just one spot. It doesn't necessarily mean it's more severe or untreatable, but it guides the type of treatment needed.

What is golcadomide?

Golcadomide is a new medication being tested in this study. We are researching how it works and if it can help improve the treatment for follicular lymphoma when given with other drugs.

Will I get standard treatment if I join?

Yes, everyone in this study will receive rituximab, which is a standard treatment for follicular lymphoma. Some patients might also receive other standard chemotherapy drugs, depending on what the study plan requires.

Can I leave the study at any time?

Absolutely. Your participation is completely voluntary, and you are free to leave the study at any point, for any reason, without it affecting your medical care.