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NCT00658814 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title 
Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (NCT00658814)

Trial Description
This phase II trial is studying the side effects of giving azacitidine (Vidaza®; Celgenetogether with the antibody-drug conjugate gemtuzumab ozogamicin (Mylotarg®; Pfitzer, Inc.) to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, (originally developed by Pharmacia and also known as 5-azacytidine; Aza-C; Azacytidine; CC-486; Ladakamycin; NS-17; NSC-102816; U-18496), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Monoclonal antibodies, including the antibody-drug conjugate gemtuzumab ozogamicin, 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. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.

This trial is sponsored by National Cancer Institute (NCI). [1]

Study Data

  • Condition:
    • Adult Acute Megakaryoblastic Leukemia
    • Adult Acute Monoblastic Leukemia
    • Adult Acute Monocytic Leukemia
    • Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
    • Adult Acute Myeloid Leukemia With Maturation
    • Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
    • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
    • Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
    • Adult Acute Myeloid Leukemia Without Maturation
    • Adult Acute Myelomonocytic Leukemia
    • Adult Erythroleukemia
    • Adult Pure Erythroid Leukemia
    • Secondary Acute Myeloid Leukemia
    • Untreated Adult Acute Myeloid Leukemia
  • Interventions:
  • Phase: II
  • Enrollment: 133
  • Start: December 2008
  • Primary Completion: June 2013

Study Schematic

(Coming soon)

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Last Editorial review: July 20, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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