Study for Patients with CD 123+ Acute Myeloid Leukemia (AML), Myelofibrosis (MF) or Chronic Myelomonocytic Leukemia (CML)

The University of Virginia Comprehensive Cancer Center is conducting a clinical research study for patients who are adults with CD-123 positive acute myeloid leukemia (AML), myelofibrosis (MF) or chronic myelomonocytic leukemia (CML) who have received an allogeneic stem cell treatment (HSCT). The purpose of this study is to learn more about the safety of a drug called tagraxofusp in this population and to gain some information on whether it may help to prevent relapse. Tagraxofusp is approved for use in another type of cancer, but not in this population, so this use of the drug is investigational. Groups of participants will receive increasing levels of the study drug, starting 60 – 120 days after HSCT.
Participants in the study will receive tagraxofusp by intravenous infusion on days 1-3 of cycles 1 through 4, and on days 1-2 in subsequent cycles. Each cycle is approximately one month. During cycle 1, tagraxofusp will be given while the patient is in the hospital, but after that, it may be given outpatient. After about 4 cycles of treatment and again about 1 year after transplant, participants will have a bone marrow biopsy and also take a questionnaire about their quality of life.
All participants will receive study treatment for as long as the treatment is working for them and they don’t have bad side effects, for up to about 9 cycles. This duration will vary among participants. Participants will still be followed even after they have completed the study treatment. Study-specific tests that are being done beyond standard of care will be provided at no cost to the patient/participant or his/her/their insurance.
Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05233618