OncoMatch/Clinical Trials/NCT07148180
A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax
Is NCT07148180 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Tagraxofusp and Azacitidine (AZA) for acute myeloid leukaemia (aml).
Treatment: Tagraxofusp · Azacitidine (AZA) · Venetoclax — The purpose of this research study is to test the safety and efficacy of a new drug combination with three agents, azacitidine, venetoclax and tagraxofusp. Leftover (residual) leukemia disease that is not visible by eye can be increase the chance of disease recurrence. This research study is to determine if the combination therapy can safely help to control residual Acute Myeloid Leukemia (AML) and to prevent disease recurrence. The names of the study drugs involved in this study are: * Tagraxofusp (a type of CD123-directed cytotoxin) * Azacitidine (a type of standard of care cytidine nucleoside analog) * Venetoclax (a type of standard of care BCL-2 inhibitor)
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: IL3RA overexpression (CD123+ by central assessment)
Any evidence of CD123+ by central assessment.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: CD123-targeted therapy
Prior treatment with CD123-targeted therapy
Cannot have received: intensive anti-leukemic chemotherapy
Exception: allowed if >2 weeks from first dose of study; if on venetoclax, must be off for at least 5 days
Subjects who received intensive anti-leukemic chemotherapy within 2 weeks from first dose of study. If on venetoclax, subjects must be off venetoclax for at least 5 days
Cannot have received: allogeneic stem cell transplant
History of prior allogeneic stem cell transplant
Lab requirements
Blood counts
Subjects must be in CR, CRi, or CRh with <5% morphologic blasts in bone marrow; Albumin ≥ 3.2 g/dL
Kidney function
Creatinine clearance ≥ 45 ml/min GFR by MDRD
Liver function
total bilirubin ≤ 1.5 x institutional upper limit of normal unless due to Gilbert or non-hepatic in origin; AST(SGOT) and ALT(SGPT) ≤ 3.0 × institutional upper limit of normal
Cardiac function
Left ventricular ejection fraction ≥ institutional lower limit of normal by MUGA or echocardiogram within 30 days of first protocol treatment
Subjects must have adequate organ and marrow function as defined below: total bilirubin ≤ 1.5 x institutional upper limit of normal unless due to Gilbert or non-hepatic in origin; AST(SGOT) and ALT(SGPT) ≤ 3.0 × institutional upper limit of normal; Creatinine clearance ≥ 45 ml/min GFR by MDRD; Albumin ≥ 3.2 g/dL; Left ventricular ejection fraction ≥ institutional lower limit of normal by MUGA or echocardiogram within 30 days of first protocol treatment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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