Gemtuzumab as Part of Chemotherapy

A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia

What's the purpose of the trial?

This phase II trial studies the side effects and how well fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride work in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and idarubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a antitumor drug, called calicheamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers calicheamicin to kill them. Colony-stimulating factors, such as filgrastim-sndz, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride may kill more cancer cells.
Trial status

Accepting patients

Phase
Phase 2
Enrollment
270
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.
  • Decitabine is a type of chemotherapy called a hypomethylating agent that interferes with the growth and spread of cancer cells in the body. 
  • Filgrastim is a bone marrow stimulant medication used to treat low white blood cell counts that are common side effects of cancer treatments. 
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Gemtuzumab Ozogamicin is an antibody drug conjugate that is approved for use in acute myeloid leukemia, and being studied for use in other indications.
  • Idarubicin is an anti-neoplastic chemotherapy drug used to treat several different kinds of cancers.

Arms / Cohorts

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Accepting patients

Filgrastim + Fludarabine + Cytarabine + Gemtuzumab + Idarubicin

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