NCT00909168

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: University Hospital, Udine, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	FLAIMy - Fluda, Ida, Ara-C, Mylotarg	FLUDARABINE: 25 mg/m2/day, 250 FS in 30', start h 9 - 1, 2, 3, 4, 5 ARABINOSYL-CYTOSINE (Cytarabine): 2 g/m2/day, 500 FS in 3 h, start h 13 - 1, 2, 3, 4, 5 IDARUBICIN: 10 mg/m2/day, 100 FS in 1 h, start h 16 - 1, 3, 5 GEMTUZUMAB OZOGAMICIN (Mylotarg): 5 mg, single dose 500 FS in 4 h - 6

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-05-01
• Completion: 2013-03-01
• First posted: 2009-05-27
• Last updated: 2014-05-06

Locations

1 site across 1 country: Italy