Clinical Trial Goal
To find out:
- The highest dose of tagraxofusp that's safe to give
- If tagraxofusp is safe and works well to treat blood cancer that has relapsed or is refractory in children, teens and young adults
You may be able to join this trial if you:
Your child:
- Is 1 to 21 years of age
- Have blood cancer that has relapsed or is refractory. Some examples include:
- Acute biphenotypic leukemia
- Acute myeloid leukemia (AML)
- Acute lymphoblastic leukemia (ALL)
- Chronic lymphocytic leukemia (CLL)
- Chronic myelomonocytic leukemia (CML)
- Hodgkin lymphoma
- Multiple myeloma
- Myelodysplastic syndrome (MDS)
- Myelofibrosis
- Non-Hodgkin lymphoma (NHL)
- Has cancer cells with mutation/marker CD123 (CD123+). Your child's doctor can tell you this
- Does not have graft versus host disease (GVHD) requiring medication
- Has not had an autologous (your own cells) or allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
- You agree to have other standard tests done to see if your child can be in the clinical trial
Trial Details
Tagraxofusp is an antibody-drug conjugate that targets CD123 on certain cells.
Your child will get treatment in cycles that last up to 1 month. In each cycle, your child will get:
Your child will get treatment in cycles that last up to 1 month. In each cycle, your child will get:
- Tagraxofusp – Given as intravenous (IV) infusions 1 time each day for 5 days
Additionally, your child will receive chemotherapy (chemo) with some of the following drugs:
- Azacitidine
- Cytarabine
- Dexamethasone
- Fludarabine
- Hydrocortisone
- Methotrexate
- Vincristine
Your child will have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your child's health to see how well the treatment is working.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat blood cancer in children, teens and young adults is new and unproven.
Contacts
Benjamin N Brookhart, 323-361-5429, bbrookhart@chla.usc.edu
Ellynore Florendo, 323-361-3022, eflorendo@chla.usc.edu
Locations
Sponsors
lead: Therapeutic Advances in Childhood Leukemia Consortium
