PVEK (IMGN632)

Phase 1 Study of FLAG-Ida With Pivekimab Sunirine (PVEK [IMGN632]) for Adults With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms

What's the purpose of the trial?

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.
Trial status

Accepting patients

Phase
Phase 1
Enrollment
30
Last Updated
1 month ago
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Participating Centers

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Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Cytarabine is an antineoplastic chemotherapy agent that is FDA approved to treat several different kinds of leukemia.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Granulocyte Colony-Stimulating Factor is a glycoprotein used to stimulate the bone marrow to help with granulocyte and stem cell production.
  • Idarubicin is an anti-neoplastic chemotherapy drug used to treat several different kinds of cancers.
  • Pivekimab Sunirine is an antibody drug conjugate that targets the CD123 protein found on some cancer cells.

Arms / Cohorts

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Accepting patients

PVEK + FLAG-Ida

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