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Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project

Recruiting
18 years of age
Both
Phase N/A

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Overview

This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms

Investigator's sites: 80-90 sites in Germany and Austria

Estimated duration of observation of an individual patient:

10 years maximum

Objectives

  • To register all patients with AML and related neoplasms, newly diagnosed or relapsed/refractory in all AMLSG participating centers (completeness)
  • To perform rapid analyses of disease-related genetic markers (incidences, treatment recommendations)
  • To assess patient and family history, as well as patient characteristics
  • To evaluate treatment response (CR, CRh, CRi) and outcome data (event-free survival [EFS], relapse-free survival [RFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • To evaluate the impact of measurable residual disease (MRD) by different methods
  • To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
  • To store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue; e.g., skin biopsy, finger nails, hairs, sputum, or urine)

Eligibility

Inclusion Criteria:

  • Patients with suspected diagnosis of acute myeloid leukemia and related neoplasms, newly diagnosed or relapsed/refractory, classified according to the International Consensus Classification
  • Age ≥ 18 years. There is no upper age limit.
  • Signed written informed consent

Exclusion Criteria:

  • Severe neurological or psychiatric disorder interfering with ability to give an informed consent
  • No consent for registration, storage and processing of the individual patient and disease characteristics and course as well as information of the family physician about study participation
  • No consent for biobanking of patient's biological specimens and performance of analyses on stored material.

Study details

Acute Myeloid Leukemia (AML), MDS/AML

NCT01252485

University of Ulm

7 June 2025

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