Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents

A treatment cycle is 28 days. Tagraxofusp will be administered at 9 mcg/kg IV over 15 minutes (-5 or +15 minutes) daily for 3 consecutive days (or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), followed by azacitidine administered at 75 mg/m2 SQ or IV daily on Day 4 through Day 10. Venetoclax will begin on Day 4 and continue through Day 24 (21 consecutive days). A bone marrow biopsy (BM Bx) will be performed on Day 24 (+3 days) of Cycle 1. Subjects who do not achieve a CRm will proceed with the next cycle of Induction Phase study tre

Trial Details

NCT ID
NCT05442216
Phase
PHASE2
Sponsor
Joshua Zeidner
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Tagraxofusp
  • Azacitidine
  • Venetoclax
Locations (sample)
  • Miami, Florida, United States|25.77427,-80.19366
  • Orlando, Florida, United States|28.53834,-81.37924
  • Buffalo, New York, United States|42.88645,-78.87837
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584
  • Winston-Salem, North Carolina, United States|36.09986,-80.24422

Key Eligibility Criteria

  • Subject must meet all of the following applicable inclusion criteria to participate in this study:
  • Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be…
  • Subjects must have newly diagnosed, untreated AML, as defined by ≥ 20% blasts in peripheral blood or bone marrow by manual aspirate differential, i…
  • Subjects must have documented CD123 positivity on leukemia cells by a centralized flow cytometry assay (Hematologics).

For full eligibility, visit ClinicalTrials.gov.

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