What is this study trying to find out about acute myeloid leukemia?

This study aims to collect detailed information about adult patients with acute myeloid leukemia and related conditions, focusing on patient characteristics, genetic markers, treatment responses, and clinical outcomes. The research seeks to better understand the disease and its progression. It is sponsored by the University of Ulm and involves multiple sites in Germany and Austria.

Who may be eligible for this acute myeloid leukemia clinical trial?

Adults 18 years or older with a suspected diagnosis of acute myeloid leukemia or related neoplasms may be eligible. Participants must be able to give informed consent and agree to data and biological specimen collection. There is no upper age limit. Please review eligibility criteria for more details.

Is there any cost to participate in this acute myeloid leukemia clinical trial?

Study-related care, including data collection and trial assessments, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Age: 18Years +

All Genders

ID01252485

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

Led by University of Ulm · Updated on 2026-01-05

50000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a registry study involving adult patients diagnosed with acute myeloid leukemia AML and related myeloid neoplasms, including newly diagnosed or relapsedrefractory cases. The study aims to collect comprehensive data on patient characteristics, family history, biological disease profiles, and clinical outcomes. It also focuses on analyzing disease-related genetic markers and the impact of measurable residual disease MRD using various methods. The study does not involve specific treatments but collects data and biological samples such as bone marrow, blood, plasma, and normal tissue including skin biopsies and other specimens. This observational study enrolls patients from around 80 to 90 sites in Germany and Austria. Patients treatment responses, decisions, and outcomes are tracked over time. Participants are observed for up to 10 years, during which researchers gather information on treatment response, survival, relapse rates, quality of life, and genetic markers. The study includes assessments of event-free survival, relapse-free survival, cumulative incidence of relapse and death, and overall survival. Patient consent is required for registration, data storage, and biobanking of specimens for analysis throughout the observation period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients with suspected diagnosis of acute myeloid leukemia and related neoplasms, newly diagnosed or relapsed/refractory, classified according to the International Consensus Classification
Age 25 18 years. There is no upper age limit.
Signed written informed consent

You will not qualify if you...

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.

Research Team

Hartmut Döhner, Prof. Dr.

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