A Phase 1 Study of Tagraxofusp With or Without Chemotherapy in Young People With Hematologic Cancers

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Full Title

A Phase I Study of Tagraxofusp With or Without Chemotherapy in Pediatric Patients with Relapsed or Refractory CD123 Expressing Hematologic Malignancies (TACL_T2020-006)

Purpose

The purpose of this study is to assess the drug tagraxofusp alone or with chemotherapy for people with blood cancers. The children, teens, and young adults in this study have cancers of the blood or lymph system. In addition, the cancers make a protein called CD123, which plays a role in cancer growth.

Tagraxofusp can strengthen the immune system’s ability to fight cancer cells. It also delivers a cancer-killing drug to cancer cells that carry the CD123 protein. By targeting CD123-positive cancer cells, tagraxofusp may slow or stop cancer growth.

The standard chemotherapy drugs used in this study include cytarabine, azacitidine, methotrexate, hydrocortisone, vincristine, dexamethasone, and fludarabine. Tagraxofusp is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You or your child must:

  • Have a hematologic cancer such as acute leukemia, myelodysplastic syndrome, Hodgkin lymphoma, or non-Hodgkin lymphoma.
  • Have hematologic cancer that carries the CD123 protein and keeps growing even with treatment.
  • Have recovered from the serious side effects of prior therapies before getting the study treatment.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 1-21 years.

Contact

For more information and to see if you or your child can join this study, please call 833-MSK-KIDS.

Protocol

23-298

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05476770