NCT00454480 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes (NCT00454480)

Trial Description
Drugs used in chemotherapy 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. Tipifarnib (Zarnestra®; Johnson & Johnson Pharmaceutical Research & Development) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with gemtuzumab ozogamicin or tipifarnib may kill more cancer cells.

This randomized phase II/III trial is studying different combination chemotherapy regimens to compare how well they work when given with or without gemtuzumab ozogamicin or tipifarnib in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes.

This trial is sponsored by University of New South Wales /National Cancer Institute (NCI). [1]

Study Data

• Condition:
  • Leukemia
  • Myelodysplastic Syndromes
• Interventions:
  • Drugs used in this trial
    • arsenic trioxide (Trisenox®; Teva Pharmaceuticals)
    • azacitidine (Vidaza®; Celgene Co.)
    • busulfan (Myleran®; GlaxoSmithKline)
    • clofarabine (Clolar®; Sanofi-Aventis U.S.)
    • cytarabine (DepoCyt®; Sigma Tau Pharmaceuticals)
    • daunorubicin (DaunoXome®; Gilead Sciences Inc.)
    • fludarabine (Fludara®; Genzyme, Inc. )
    • gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories)
    • melphalan (Alkeran®; GlaxoSmithKline)
    • tipifarnib (Zarnestra®; Johnson & Johnson Pharmaceutical Research & Development)
  • Genetic: DNA methylation analysis
  • Genetic: cytogenetic analysis
  • Genetic: gene expression analysis
  • Genetic: mutation analysis
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunologic technique
  • Procedure: allogeneic hematopoietic stem cell transplantation
  • Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
• Phase: II & III
• Estimated Enrollment: 2000
• Start: August 2006
• Primary Completion: August 2012

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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