NCT00077116 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome (NCT00077116)

Trial Description
Drugs used in chemotherapy, such as Idarubicin (Idamycin®; Pfitzer, Inc.) and cytarabine (DepoCyt®; Sigma Tau Pharmaceuticals), work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, including the antibody-drug conjugates or ADCs such as gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories), can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells. Giving healthy stem cells from a donor whose blood closely resembles the patient’s blood will help the patient’s bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.

This phase II trial is studying how well giving idarubicin and cytarabine together with gemtuzumab ozogamicin works in treating patients with previously untreated high-risk myelodysplastic syndrome or acute myeloid leukemia secondary to myelodysplastic syndrome.

This trial is sponsored by European Organisation for Research and Treatment of Cancer (EORTC). [1]

Study Data

Study Schematic

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Last Editorial review: July 22, 2015
Information based on (NIH/NCI) and other sources.

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