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More info
You can access this
clinical trial
if you have
Acute Myeloid Leukemia
and you are
between 18 and 65
years old
2
3
This is an advanced phase trial assessing
the effectiveness of the new treatment before being released on the market.
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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)