Clinical Trial Goal
To find out if golcadomide with R-CHOP standard chemo is safe and works well to treat high-risk LBCL that has not yet been treated
You may be able to join this trial if you:
- Are 18 – 80 years old
- Have high-risk LBCL that has not yet been treated. Some examples include:
- Diffuse large B-cell lymphoma (DLBCL)
- T-cell histiocyte rich large B-cell lymphoma
- Epstein-Barr virus (EBV+) DLBCL
- 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
Golcadomide is a small molecule inhibitor that blocks CRBN in certain cells.
R-CHOP, which includes:
R-CHOP, which includes:
- Cyclophosphamide, doxorubicin, and vincristine - These are chemo drugs that block the growth of cancer cells
- Prednisone - This is a drug that reduces inflammation
- Rituximab - This 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 and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
- Group 1 – Standard chemo (R-CHOP), plus golcadomide
- Group 2 – Standard chemo (R-CHOP) plus placebo
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 treatment in cycles. In each cycle you'll get:
- R-CHOP– Each drug is given separately as either intravenous (IV) infusions, shots, or pills that you take by mouth
- Golcadomide – Group 1 only - A pill that you take by mouth
- Placebo - Group 2 only - A pill that you take by mouth with no medicine in it
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 5.5 years.
The Food and Drug Administration (FDA) has approved R-CHOP to treat LBCL. The FDA has not yet approved golcadomide.
Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
Locations
Sponsors
lead: Celgene
