NCT00895934 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Vorinostat, Azacitidine, and Gemtuzumab Ozogamicin for Older Patients With Relapsed or Refractory AML (NCT00895934)

Trial Description
The purpose of this study is to test the safety of vorinostat (Zolinza®; Merck & Co.) and azacitidine (Vidaza®; Celgenewhen combined with the antibody-drug conjugate gemtuzumab ozogamicin (GO) (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories)  at different dose levels. These drugs increase the effect of gemtuzumab ozogamicin (GO) against leukemia cells in the test tube, but we don’t know yet whether they also increase the anti-leukemia effect of GO in people.

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

Study Data

  • Conditions:
    • Adult Acute Megakaryoblastic Leukemia (M7)
    • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
    • Adult Acute Monoblastic Leukemia (M5a)
    • Adult Acute Monocytic Leukemia (M5b)
    • Adult Acute Myeloblastic Leukemia With Maturation (M2)
    • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
    • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
    • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
    • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
    • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
    • Adult Acute Myelomonocytic Leukemia (M4)
    • Adult Erythroleukemia (M6a)
    • Adult Pure Erythroid Leukemia (M6b)
    • Recurrent Adult Acute Myeloid Leukemia
  • Interventions:
  • Phase: I & II
  • Enrollment: 53
  • Start: May 2009
  • Completion: September 2013
  • Last verified: July 2012

Study Schematic

(Coming soon)

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

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