NCT00136084 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia (NCT00136084)

Trial Description
The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy regimens using different dosages of cytarabine (DepoCyt®; Sigma Tau Pharmaceuticals) to eliminate all detectable leukemia.

This trial is sponsored by St. Jude’s Children’s Research Hospital/ National Cancer Institute (NCI). [1]

Study Data

• Condition: Acute Myelocytic Leukemia
• Interventions:
  • Drugs used in this trial
    • Multi-Agent Chemotherapy Regime I:
      • cladribine (Leustatin; Janssen Pharmaceuticals)
      • cyclophosphamide (ProCytox®;Baxter Co)
      • cytarabine (DepoCyt®; Sigma Tau Pharmaceuticals)
      • daunorubicin (DaunoXome®; Gilead Sciences Inc.)
      • dexamethasone (Ozurdex®; Allergan)
    • Multi-Agent Chemotherapy Regime II:
      • etoposide (Toposar®; Pfitzer, Inc.)
      • cytarabine (DepoCyt®; Sigma Tau Pharmaceuticals)
      • gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories)
      • asparaginase (Elspar®; Merck & Co.)
      • mercaptopurine (Purixan®; Rare Disease Therapeutics Inc.)
      • methotrexate (Trexall®; Teva Pharmaceuticals)
      • mitoxantrone hydrochloride (Novantrone®; EMD Serono/Merck & Co.)
      • prednisolone (Orapred®; Concordia Healthcare Corp.)
      • vincristine (Oncovin®; Thornton & Ross Ltd./ Genus Pharmaceuticals)
• Phase: III
• Enrollment: 238
• Start: August 2002
• Completion: June 2012
• Last verified: November 2012

Study Schematic

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Last Editorial review: July 24, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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