NCT00909168 (MYFLAI07) (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML) (MYFLAI07) (NCT00909168)

Trial Description
This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.

Trial is based on:

  • INDUCTION: FLAI + (FLAI-GO). gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories)
  • CONSOLIDATION: Intermediate dose + IDA (IDAC+IDA) +/- one course of high dose (HDAC) cytarabine (DepoCyt®; Sigma Tau Pharmaceuticals)
  • INTENSIFICATION: Allo-BMT, ASCT
  • MAINTENANCE: AraC a) Primary endpoints:
  • Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
  • RFS, DFS and OS. b) Secondary endpoints:
  • Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
  • Evaluation of prognostic clinical relevance of biological features at onset.
  • Feasibility and outcome of consolidation with BMT.

This trial is sponsored by University Hospital, Udine, Italy; European Society for Medical Oncology (ESMO). [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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