OncoMatch/Clinical Trials/NCT05442216
Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents
Is NCT05442216 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tagraxofusp and Azacitidine for acute myeloid leukemia.
Treatment: Tagraxofusp · Azacitidine · Venetoclax — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IL3RA overexpression (CD123 positivity on leukemia cells by centralized flow cytometry)
Subjects must have documented CD123 positivity on leukemia cells by a centralized flow cytometry assay (Hematologics).
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hypomethylating agent (azacitidine, decitabine, oral decitabine/cedazuridine) — for MDS, CMML, MDS/MPN overlap syndromes, or MPN's
Subjects must have received at least 2 cycles of hypomethylating agents (azacitidine or decitabine or oral decitabine/cedazuridine) for the management of MDS, CMML, MDS/MPN overlap syndromes, or MPN's.
Cannot have received: tagraxofusp (tagraxofusp)
Previous receipt of tagraxofusp.
Cannot have received: chemotherapy
Exception: hydroxyurea, leukapheresis and/or cyclophosphamide allowed prior to study entry per protocol
Treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of registration. NOTE: hydroxyurea, leukapheresis and/or cyclophosphamide are allowed prior to study entry per the protocol.
Cannot have received: biologic therapy
Treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of registration.
Cannot have received: wide-field radiation
Treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of registration.
Cannot have received: investigational drug
Treatment with investigational drug within 21 days of registration.
Cannot have received: allogeneic stem cell transplant
Previous allogeneic stem cell transplant within 60 days prior to registration.
Lab requirements
Blood counts
Demonstrate adequate organ function within 28 days prior to registration.
Kidney function
Demonstrate adequate organ function within 28 days prior to registration.
Liver function
Demonstrate adequate organ function within 28 days prior to registration.
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 45%. No uncontrolled CHF, cardiac insufficiency Grade III or IV (NYHA), uncontrolled angina/hypertension/arrhythmia, significant ECG abnormalities, or history of MI/stroke within 6 months.
Demonstrate adequate organ function within 28 days prior to registration. Left ventricular ejection fraction (LVEF) ≥ 45%. Clinically significant cardiovascular disease including: Uncontrolled CHF, Cardiac insufficiency Grade III or IV per New York Heart Association (NYHA) classification, Uncontrolled angina/hypertension/arrhythmia, Clinically significant abnormalities on a 12-lead electrocardiogram, History of myocardial infarction or stroke within 6 months of registration.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
- AdventHealth Orlando · Orlando, Florida
- Roswell Park Cancer Institute · Buffalo, New York
- University of North Carolina at Chapel Hill · Chapel Hill, North Carolina
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center · Winston-Salem, North Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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