Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a risk-adapted, minimal-residual-disease
      directed therapy for young adults with newly diagnosed acute myeloid leukemia has positive
      results in terms of overall survival at 24 months.
    

Detailed description: 
      The general objective of this study is that of setting up a multicentre, risk-adapted study
      that relies on pre-treatment cytogenetic/genetic features and post-consolidation assessment
      of Minimal Residual Disease (MRD) to establish the final risk assignment and treatment of
      younger (≤ 60 years) patients with Acute Myeloid Leukemia (AML). Aim of this clinical trial
      is to verify whether the delivery of a post remission therapy whose intensity is risk-driven
      will improve the outcome in terms of both increased anti-leukemic efficacy and reduced
      therapy-related toxicity.

      All patients will receive induction and consolidation chemotherapy according to the Gruppo
      Italiano Malattie EMatologiche dell'Adulto (GIMEMA) LAM99P protocol. After the first
      consolidation, patients belonging to the low-risk category (core binding factor positive AML
      without c-Kit mutations, NPM1 positive FLT3 negative AML) will receive autologous stem cell
      transplantation, patients with high-risk features (adverse-risk karyotype, FLT3-ITD
      mutations), will be assigned to allogeneic stem cell transplantation. Patients with FLT3-TKD
      mutations or c-Kit mutated core binding factor positive AML and those belonging to the
      intermediate-risk karyotype category will be stratified according to MRD by flow cytometry
      and will receive risk-adapted treatment (autologous vs. allogeneic stem cell
      transplantation). All patients who meet the criteria for high-risk definition will be offered
      the allogeneic transplantation option regardless of the availability of a Human Leukocyte
      Antigen (HLA) identical sibling. In fact, for those lacking a HLA identical sibling all the
      other sources of hematopoietic stem cells (matched unrelated donor from international
      registry, unrelated cord blood, family haploidentical donor) will be considered. Autologous
      or allogeneic stem cell transplantation will be performed within 3 months from the end of
      consolidation therapy.
    

Intervention name(s): Risk-adapted, MRD-directed therapy
Intervention type(s): Other
Intervention description(s): The general objective of this study is that of setting up a multicentre, risk-adapted study that relies on pre-treatment cytogenetic/genetic features and post-consolidation assessment of MRD to establish the final risk assignment and treatment of younger (≤ 60 years) patients with AML. Aim of this clinical trial is to verify whether the delivery of a post remission therapy whose intensity is risk-driven will improve the outcome in terms of both increased anti-leukemic efficacy and reduced therapy-related toxicity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute myeloid leukemia; risk-adapted therapy; MRD-directed therapy; young adults