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)
  • 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

(Coming soon)

Click here to Return to Drug map

Last Editorial review: July 23, 2015
Information based on (NIH/NCI) and other sources.

Copyright © 2015 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.

Add to Flipboard Magazine.