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

Summary

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 + Gemtuzumab-Ozogamicin (FLAI-GO). * CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC (HDAC) * 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.

Timeline

Start

2008-03

Primary completion

2009-05

Completion

2013-03

Publications

• Candoni A, Papayannidis C, Martinelli G, Simeone E, Gottardi M, Iacobucci I, Gherlinzoni F, Visani G, Baccarani M, Fanin R. Flai (fludarabine, cytarabine, idarubicin) plus low-dose Gemtuzumab Ozogamicin as induction therapy in CD33-positive AML: Final results and long term outcome of a phase II multicenter clinical trial. Am J Hematol. 2018 May;93(5):655-663. doi: 10.1002/ajh.25057. Epub 2018 Mar 2.

Drugs

Indications