Clinical Trial Goal
To find out:
- The highest dose of dexamethasone, inotuzumab ozogamicin and venetoclax that's safe to give
- If the combination of dexamethasone, inotuzumab ozogamicin and venetoclax is safe and works well to treat B-ALL that has relapsed or is refractory in children and adults
You may be able to join this trial if you:
- Are 1- 39 years old
- Have B-ALL that has relapsed or is refractory
- Have not had a blood or marrow transplant (BMT) in the last 3 months
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Dexamethasone is a drug that reduces inflammation.
Inotuzumab ozogamicin is an antibody-drug conjugate that targets CD22 on certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
You’ll get:
Inotuzumab ozogamicin is an antibody-drug conjugate that targets CD22 on certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
You’ll get:
- Dexamethasone – The dose you'll get depends on when you start the trial and how safe it has been]
- Inotuzumab ozogamicin – Given as intravenous (IV) infusions 1 time each week
- Venetoclax – A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 4 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat B-ALL that has relapsed or is refractory in children and adults is new and unproven.
Contacts
Jeremy Rubinstein, MD, PhD, 513-636-2799, jeremy.rubinstein@cchmc.org
Site Primary Contact Cancer line, 513-636-2799, cancer@cchmc.org
Locations
Cincinnati Children's Hospital Medical CenterRECRUITING
Cincinnati, Ohio
Sponsors
lead: Children's Hospital Medical Center, Cincinnati
