Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies

Tagraxofusp is a protein-drug conjugate consisting of a diphtheria toxin redirected to target CD123 has been approved for treatment in pediatric and adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). This trial aims to examine the safety of this novel agent in pediatric patients with relapsed/refractory hematologic malignancies. The mechanism by which tagraxofusp kills cells is distinct from that of conventional chemotherapy. Tagraxofusp directly targets CD123 that is present on tumor cells, but is expressed at lower or levels or absent on normal hematopoietic stem cell

Trial Details

NCT ID
NCT05476770
Phase
PHASE1
Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • Tagraxofusp
  • Fludarabine
  • Cytarabine
  • Dexamethasone
  • Vincristine
  • Azacitidine
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311
  • San Francisco, California, United States|37.77493,-122.41942
  • Denver, Colorado, United States|39.73915,-104.9847
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637

Key Eligibility Criteria

  • Patients must be ≥ 1 and ≤21 years of age at the time of study enrollment.
  • Relapsed and/or refractory hematologic malignancy (including, but not limited to, acute lymphoblastic leukemia, acute myeloid leukemia, myelodyspla…
  • Tumor cells must demonstrate surface expression of CD123 at the time of enrollment by flow cytometry or immunohistochemistry, as defined by the loc…
  • Disease Status:

For full eligibility, visit ClinicalTrials.gov.

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