NCT00121303 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes (NCT00121303)

Trial Description
Drugs used in chemotherapy, such as cytarabine (DepoCyt®; Sigma Tau Pharmaceuticals) and daunorubicin (DaunoXome®; Gilead Sciences Inc.), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Monoclonal antibodies, such as the antibody-drug conjugates or ADCs gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories), can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether cytarabine and daunorubicin followed by gemtuzumab ozogamicin is more effective than cytarabine and daunorubicin in treating acute myeloid leukemia or myelodysplastic syndromes.

This randomized phase III trial is studying cytarabine and two different doses of daunorubicin to see how well they work compared to cytarabine and daunorubicin followed by gemtuzumab ozogamicin in treating older patients with acute myeloid leukemia or myelodysplastic syndromes.

This trial is sponsored by Stichting Hemato-Oncologie voor Volwassenen Nederland. [1]

Study Data

Study Schematic

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Last Editorial review: July 23, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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