Clinical Trial Goal
To find out if the combination of golcadomide and rituximab is safe and works well to treat follicular lymphoma that has relapsed or is refractory, compared to rituximab and standard therapy
You may be able to join this trial if you:
- Are 18 years old or older
- Have follicular lymphoma, grade 1a-3a
- Do not have any of the following:
- Diffuse large B-cell lymphoma (DLBCL)
- Follicular lymphoma grade 3b
- Transformed non-Hodgkin lymphoma (NHL)
- Do not have lymphoma in your brain or spinal cord
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Bendamustine is a chemotherapy (chemo) drug that blocks the growth of cancer cells.
Glocadomide is a cereblon E3 ligase modulator (CELMoD) agent.
R-CHOP is a type of treatment that includes standard chemo with the following drugs: cyclophosphamide, doxorubicin, lenalidomide, prednisone and vincristine.
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
Glocadomide is a cereblon E3 ligase modulator (CELMoD) agent.
R-CHOP is a type of treatment that includes standard chemo with the following drugs: cyclophosphamide, doxorubicin, lenalidomide, prednisone and vincristine.
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – Golcadomide plus rituximab
- Group 2 – Rituximab plus R-CHOP OR rituximab plus bendamustine
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You’ll get:
- Bendamustine – Group 2 only - Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
- Golcadomide – Group 1 only - A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
- R-CHOP – Group 2 only - Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been
- Rituximab – Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been
You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 3 years.
The Food and Drug Administration (FDA) has not yet approved golcadomide.
Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 8559073286, Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
Locations
Sponsors
lead: Celgene
