Condition: Acute Myeloid Leukemia · Sponsor: Joshua Zeidner
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 treatment, irrespective of hematologic laboratory values. Cycle 2+ will consist of tagraxofusp 9 mcg/kg IV over 15 minutes daily for 3 consecutive days (Day 1-3 or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), azacitidine 75 mg/m2 SQ or IV on Day 1 through Day 7 or Days 1-7 or 1-5, 8-9 and venetoclax 400 mg daily Day 1 through Day 21. A bone marrow biopsy (BM Bx) will be performed on Day 21 (+3 days) of Cycle 2. If a CRm is obtained or maintained, the subject will move to or remain on the Continuation Phase. Subjects who do not achieve a marrow CR (CRm) after Cycle 2 will proceed with the next cycle of Induction Phase study treatment as described above, irrespective of hematologic laboratory values. If a CRm is obtained after Cycle 3 or 4, the subject will move to the Continuation Phase . If a CRm is not obtained after Cycle 4, …
This description comes directly from the study's public registry record.
Joshua Zeidner, MD · 732-236-3903 · joshua_zeidner@med.unc.edu
LeaEtta Hyer · 317-634-5842 · lhyer@hoosiercancer.org
Always discuss trial participation with your own doctor first.
| University of Miami | Miami, Florida, United States | Recruiting |
| AdventHealth Orlando | Orlando, Florida, United States | Recruiting |
| Roswell Park Cancer Institute | Buffalo, New York, United States | Recruiting |
| University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, United States | Recruiting |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem, North Carolina, United States | Recruiting |
| Penn Medicine Abramson Cancer Center | Philadelphia, Pennsylvania, United States | Recruiting |
| Lifespan Health System Rhode Island Hospital | Providence, Rhode Island, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05442216