OncoMatch/Clinical Trials/NCT06034470
Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms
Is NCT06034470 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for acute myeloid leukemia.
Treatment: Cytarabine · Fludarabine · Granulocyte Colony-Stimulating Factor · Idarubicin · Pivekimab Sunirine — This phase I trial finds the best dose of PVEK when given together with fludarabine, cytarabine, granulocyte colony-stimulating factor (G-CSF), and idarubicin, (FLAG-Ida) regimen and studies the effectiveness of this combination therapy in treating patients with newly diagnosed adverse risk acute myeloid leukemia (AML) and other high-grade myeloid neoplasms. PVEK is a monoclonal antibody linked to a chemotherapy drug. PVEK is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors, and delivers the chemotherapy drug to kill them. Chemotherapy drugs, such as idarubicin, fludarabine, high-dose cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. G-CSF helps the bone marrow make more white blood cells in patients with low white blood cell count due to cancer treatment. Giving PVEK with the FLAG-Ida regimen may be a safe and effective treatment for patients with acute myeloid leukemia and other high-grade myeloid neoplasms.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Biomarker criteria
Required: IL3RA expression (positive)
Excluded: FLT3 mutation
Prior therapy
Cannot have received: investigational anti-leukemia agent
Lab requirements
Kidney function
Creatinine clearance ≥ 60 mL/min
Liver function
Bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis; AST and ALT ≤ 3.0 x IULN unless elevation is thought to be due to hepatic infiltration by AML
Cardiac function
Left ventricular ejection fraction ≥ 45%, assessed by MUGA scan or echocardiography or other appropriate diagnostic modality and no clinical evidence of congestive heart failure
Bilirubin ≤ 1.5 x IULN unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis; AST and ALT ≤ 3.0 x IULN unless elevation is thought to be due to hepatic infiltration by AML; Creatinine clearance ≥ 60 mL/min; Left ventricular ejection fraction ≥ 45%, assessed by MUGA scan or echocardiography or other appropriate diagnostic modality and no clinical evidence of congestive heart failure
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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