Clinical Trial Goal
To find out:
- The highest dose of gemtuzumab that’s safe to give with liposomal cytarabine-daunorubicin
- If the combination of liposomal cytarabine-daunorubicin and gemtuzumab is safe and works well to treat AML that has not yet been treated
You may be able to join this trial if you:
- Are 18 – 70 years old
- Have AML that has not yet been treated
- Have leukemia cells with CD33 markers. Your doctor can tell you this
- Do not have acute promyelocytic leukemia
- Do not have leukemia cells in your brain or spinal cord
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Liposomal cytarabine-daunorubicin is a combination of 2 drugs: cytarabine and daunorubicin. Both are chemotherapy (chemo) drugs that block growth of cancer cells.
Gemtuzumab is a monoclonal antibody-drug conjugate that targets CD33 on certain cells.
You’ll get:
Gemtuzumab is a monoclonal antibody-drug conjugate that targets CD33 on certain cells.
You’ll get:
- Gemtuzumab – Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
- Liposomal cytarabine-daunorubicin – Given as IV infusions
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 5 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them together to treat newly diagnosed AML is new and unproven.
Locations
Moffitt Cancer CenterRECRUITING
Tampa, Florida
Contacts:
- Lisa Nardelli, 813-745-4731, lisa.nardelli@moffitt.org
- Onyee Chan, 1-813-745-2069, Onyee.Chan@moffitt.org
Sponsors
collaborator: Jazz Pharmaceuticals, lead: H. Lee Moffitt Cancer Center and Research Institute
