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NCT00893399 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Study of Chemotherapy in Combination With All-trans Retinoic Acid (ATRA) With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia (AML) and Mutant Nucleophosmin-1 (NPM1) Gene Mutation (NCT00893399)

Trial Description
Randomized Phase III, two-arm, open-label, multi-center study in adult patients with Acute Myeloid Leukemia (AML) and Mutant Nucleophosmin-1 (NPM1) mutation.

Primary Efficacy Objective
Evaluation of efficacy based on event-free survival (EFS) after induction and consolidation chemotherapy plus all-trans retinoic acid (ATRA) with or without the antibody-drug conjugate gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories) in adult patients with acute myeloid leukemia (AML) and mutant nucleophosmin-1 (NPM1).

This trial is sponsored by University of Ulm. [1]

Study Data

  • Condition: Acute Myeloid Leukemia
  • Interventions:
  • Phase: III
  • Estimated Enrollment: 588
  • Start: February 2010
  • Estimated Completion: January 2020
  • Last verified: July 2014

Study Schematic

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Last Editorial review: July 21, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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