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)
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. 
- Condition: Acute Myeloid Leukemia
- Phase: III
- Estimated Enrollment: 588
- Start: February 2010
- Estimated Completion: January 2020
- Last verified: July 2014
Last Editorial review: July 21, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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