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Registry of patient characteristics and outcomes in acute myeloid leukemia

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

Observational University of Ulm · NCT01252485

This study is gathering information from adults with newly diagnosed or returning acute myeloid leukemia to see how different factors affect their treatment and survival over time.

Quick facts

Study typeObservational
Enrollment50000 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Ulm Academic / other
Locations94 sites (Graz and 93 other locations)
Trial IDNCT01252485 on ClinicalTrials.gov

What this trial studies

This registry study focuses on adult patients with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) and related neoplasms. It aims to collect comprehensive data on patient characteristics, biological disease profiles, and clinical outcomes over a maximum observation period of 10 years. The study will analyze genetic markers, treatment responses, and survival rates, while also assessing the impact of measurable residual disease on patient outcomes. Conducted across 80-90 sites in Germany and Austria, it seeks to enhance understanding of AML and improve treatment recommendations.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed or relapsed/refractory acute myeloid leukemia or related neoplasms.

Not a fit: Patients with severe neurological or psychiatric disorders that prevent informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and better outcomes for patients with acute myeloid leukemia.

How similar studies have performed: Other studies focusing on registry data and genetic profiling in AML have shown promise, indicating that this approach could yield valuable insights.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Graz and 93 other locations

+44 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaMDS/AMLAMLRegistry studyBiology and Outcome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.