Clinical Trial Goal
To find out:
- The highest dose of epcoritamab that’s safe to give with or without lenalidomide, venetoclax or standard chemo
- If epcoritamab is safe and works well to treat CLL that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have CLL that has relapsed or is refractory
- Have had a least 2 different types of treatment for the CLL
- Have been treated with a drug that’s a BTK inhibitor. Your doctor can tell you this
- Have leukemia cells with CD20 marker on them (CD20+). Your doctor can tell you this
- Do not have Richter transformation
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Epcoritamab is a bispecific monoclonal antibody that targets CD3 and CD20 on certain cells.
Lenalidomide is a drug that blocks growth of cancer cells.
Rituximab, cyclophosphamide, doxorubicin and vincristine are all chemo drugs that block the growth of cancer cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you’ll be placed in 1 of 4 groups:
Lenalidomide is a drug that blocks growth of cancer cells.
Rituximab, cyclophosphamide, doxorubicin and vincristine are all chemo drugs that block the growth of cancer cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you’ll be placed in 1 of 4 groups:
- Group 1 – Epcoritamab
- Group 2 – Epcoritamab plus lenalidomide
- Group 3 - Epcoritamab plus venetoclax
- Group 4 - Epcoritamab plus standard chemo
You’ll get treatment in cycles that last about 1 month. In each cycle, you'll get:
- Epcoritamab – Given as a shot under your skin 1 time each month. The dose you’ll get depends on when you start the trial and how safe it’s been.
- Cyclophosphamide - Group 4 only - Given as an IV infusion 1 time
- Doxorubicin - Group 4 only - Given as an IV infusion 1 time
- Lenalidomide - Group 2 only - A pill that you take by mouth 1 time each day for 3 weeks
- Rituximab - Group 4 only - Given as an IV infusion 1 time
- Venetoclax - Group 3 only - A pill that you take by mouth 1 time each day
- Vincristine - Group 4 only - Given as an IV infusion 1 time
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 3 years after your last dose.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial.
Locations
Sponsors
collaborator: AbbVie, collaborator: Eli Lilly and Company, lead: Genmab
