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

• Status: Completed
• Trial end date: 2013-03-01

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.

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: University Hospital, Udine, Italy
• Treatments: Gemtuzumab