Clinical Trial Goal
To find out:
- The highest dose of tulmimetostat that’s safe to give
- If tulmimetostat, alone or with irinotecan, is safe and works well to treat DLBCL or PTCL that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have DLBCL or PTCL that has relapsed or is refractory
- Have not had a blood or marrow transplant (BMT)
- Have not been treated with a EZH2 inhibitor. Your doctor can tell you this
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Tulmimetostat is a small molecule inhibitor that blocks EZH2 in certain cells.
Irinotecan is a small molecule inhibitor that blocks topoisomerase I in certain cells.
There are 2 parts of this trial. You’ll be placed in 1 part depending on you join the trial:
- Part 1 – CPI-0209
- Part 2 – CPI-0209 plus irinotecan
You’ll get:
- CPI-0209 – A pill that you take by mouth 1 time each day or 1 time each day for the first 3 weeks of each month. The dose you'll get depends on when you start the trial and how safe it has been
- Irinotecan – (Group 2 only) - Given as intravenous (IV) infusions 1 time each month
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for 2.5 years.
The Food and Drug Administration (FDA) has approved irinotecan to treat colon cancer. Using it to treat DLBCL is new and unproven. The FDA has not yet approved tulmimetostat.
Contacts
Novartis Pharmaceuticals, +41613241111, novartis.email@novartis.com
Novartis Pharmaceuticals, 1-888-669-6682, novartis.email@novartis.com
Locations
Sponsors
lead: Novartis Pharmaceuticals
