Clinical Trial Goal
To find out:
- The best dose and schedule of selinexor that’s safe to give with standard chemo
- If the combination of standard chemo and selinexor is safe and works well to treat DLBCL that has relapsed or is refractory, compared to standard chemo alone
You may be able to join this trial if you:
- Are 18 years old or older
- Have DLBCL or double hit lymphoma (DHL) that has relapsed or is refractory
- Have not been treated with selinexor or another drug that blocks XPO1 in certain cells. Your doctor can tell you this.
- Do not have untreated lymphoma in your brain or spinal cord
- Are not planning to be treated with CAR T-cell therapy
- Are not planning to be treated with a blood or marrow transplant (BMT)
- Have not been treated with CAR T-cell therapy in the last 3 months
- Have not had an autologous (your own cells) BMT in the last 3 months
- Have not had an allogeneic (cells from a donor) BMT in the last 6 months
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Cisplatin and gemcitabine are drugs that block the growth of cancer cells.
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
Selinexor is a small molecule inhibitor that blocks XPO1 in certain cells.
In this trial, you’ll be randomized to 1 of 3 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:
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
Selinexor is a small molecule inhibitor that blocks XPO1 in certain cells.
In this trial, you’ll be randomized to 1 of 3 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-GDP)
- Group 2 – Standard chemo (R-GDP) plus selinexor
- Group 3 – Standard chemo (R-GDP) plus selinexor and placebo
Randomized means doctors will use a computer to assign you to a 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 that last 3 weeks. In each cycle, you'll get:
- Cisplatin – Given as intravenous (IV) infusions 1 time each cycle for up to 4.5 months
- Dexamethasone – Given as IV infusions or as a pill that you take by mouth for the first 4 days of each cycle for up to 4.5 months
- Gemcitabine – Given as IV infusions 1 time each week for the first 2 weeks of each cycle for up to 4.5 months
- Rituximab – Given as IV infusions 1 time each cycle for up to 4.5 months
- Selinexor – Group 2 and Group 3 only – A pill that you take by mouth 1 time each week for the first 2 weeks of each cycle. After 4.5 months, you'll take this 1 time each week
- Placebo – Group 3 only – A pill that you take by mouth with no medicine in it 1 time each week after you've been treated with selinexor for 4.5 months
You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them together in this way to treat DLBCL that has relapsed or is refractory is new and unproven.
Locations
Sponsors
lead: Karyopharm Therapeutics Inc
