Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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, study treatment will be discontinued and the subject will move to follow up. If per the investigator, the subject is receiving clinical benefit, study treatment may continue until toxicity or completion of 12 total cycles. A BM Bx will be performed at least every 3 cycles for these subjects.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Nowo rozpoznana białaczka ostra (nielechona wcześniej) z co najmniej 20% blasków w krwi lub szpiku
- •Komórki białaczki muszą mieć dodatni marker CD123 (potwierdzony specjalnym badaniem)
- •Wcześniejsza diagnoza zespołu mielodysplastycznego lub podobnego schorzenia krwi
- •Wcześniejsze leczenie co najmniej 2 cyklami azacytydyny lub decytabiny
- •Liczba białych krwinek poniżej 30 000/µL (przed rozpoczęciem leczenia)
- •Wiek co najmniej 18 lat
- •Świadoma zgoda na udział w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (7)
University of Miami
Miami, United States
AdventHealth Orlando
Orlando, United States
Roswell Park Cancer Institute
Buffalo, United States
University of North Carolina at Chapel Hill
Chapel Hill, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, United States
Penn Medicine Abramson Cancer Center
Philadelphia, United States
Lifespan Health System Rhode Island Hospital
Providence, United States
Trial contact
Joshua Zeidner, MD
LeaEtta Hyer
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/11/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.