Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia. GIMEMA Protocol AML1310. EudraCT Number 2010-023809-36
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment strategy in terms of Overall Survival (OS) at 24 months.
OS is defined as the time interval between the date of study entry and death for any cause; patients still alive will be censored at the time of the last follow-up.
24 months from study entry.
Adriano VENDITTI, Pr.
Policlinico Tor Vergata di Roma
Italy: Ethics Committee