Clinical Trial Goal
To find out if axicabtagene ciloleucel is safe and works well to treat high-risk large B-cell lymphoma
You may be able to join this trial if you:
- Are 18 years or older
- Have large B-cell lymphoma that doctors consider high-risk. Some examples include:
- Diffuse large B-cell lymphoma (DLBCL)
- High-grade B-cell lymphoma
- Do not have any of the following:
- Burkitt lymhpoma
- Lymphoma in your brain or spinal cord
- Primary mediastinal large B-cell lymphoma (PMBCL)
- Have not had more than 1 cycle of chemotherapy (chemo) plus rituximab
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. Axicabtagene ciloleucel is a type of CAR T-cell therapy that helps your own immune system find and destroy cancer cells.
Cyclophosphamide, doxorubicin, etoposide, fludarabine, and vincristine are chemo drugs that block the growth of cancer cells.
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:
Cyclophosphamide, doxorubicin, etoposide, fludarabine, and vincristine are chemo drugs that block the growth of cancer cells.
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 – Axicabtagene ciloleucel
- Group 2 – Chemo with standard drugs plus rituximab
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.
If you're in group 1, you'll get CAR T cells. To make CAR T cells, T cells are collected from you by apheresis. Apheresis is a process to collect cells from the bloodstream using a needle similar to when you donate blood. The T cells are genetically modified to grow special proteins called CARs. CARs help T cells find the cancer cells. The CAR T cells are grown in a lab until there are millions of them. Then, they’re given back to you to find and destroy the cancer cells.
Before the CAR T-cell infusion, you’ll get chemo with 2 standard drugs:
- Cyclophosphamide – Given as intravenous (IV) infusions for 3 days
- Fludarabine – Given as IV infusions for 3 days
Next, the CAR T cells are given to you through an IV infusion. The dose of cells you’ll get depends on when you start the trial and how safe it has been.
If you’re in Group 2, you’ll get standard chemo with the following drugs given by IV infusions:
- Cyclophosphamide
- Doxorubicin
- Etoposide
- Rituximab
- Vincristine
You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 15 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial.
Watch a video about CAR T-Cell Therapy
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Locations
Sponsors
lead: Kite, A Gilead Company
