This trial is completed!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
4Get in touch
More info
You can access this
clinical trial
if you have
Acute Myeloid Leukemia
and you are
between 18 and 65
years old
This is an advanced phase trial assessing
the effectiveness of the new treatment before being released on the market.
Show me locations

The purpose

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.

Provided treatments

  • Drug: FLAIMy - Fluda, Ida, Ara-C, Mylotarg
Tris trial is registered with FDA with number: NCT00909168. The sponsor of the trial is University Hospital, Udine, Italy and it is looking for 130 volunteers for the current phase.
Official trial title:
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)