Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia

NCT01452646 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 515

Last updated 2018-08-06

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Risk-adapted, MRD-directed therapy

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.

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Principal Investigators

  • Adriano VENDITTI, Pr. · Policlinico Tor Vergata di Roma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2017-07-31
Completion
2018-07-10

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452646 on ClinicalTrials.gov