NCT01252485: AMLSG BiO

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 now Last updated 5 January 2026

What this trial tests

trial in Acute Myeloid Leukemia (AML) in 50,000 participants. Currently enrolling.

Timeline

6 July 2010

Primary endpoint
31 December 2044

31 December 2044

Quick facts

Lead sponsor	University of Ulm
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	50,000
Start date	6 July 2010
Primary completion	31 December 2044
Estimated completion	31 December 2044
Sites	94 locations across Austria, Germany

Conditions studied

• Acute Myeloid Leukemia (AML) — all drugs for Acute Myeloid Leukemia (AML) →
• MDS/AML — all drugs for MDS/AML →

Sponsor

University of Ulm

Who can join

18 and older, any sex, with Acute Myeloid Leukemia (AML) or MDS/AML. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epidemiological, genetic, and clinical characterization by age of newly diagnosed acute myeloid leukemia based on an academic population-based registry study (AMLSG BiO).
   Nagel G, Weber D, Fromm E, Erhardt S, et al · · 2017 · cited 115× · PMID 29090343 · DOI 10.1007/s00277-017-3150-3
2. getITD for FLT3-ITD-based MRD monitoring in AML.
   Blätte TJ, Schmalbrock LK, Skambraks S, Lux S, et al · · 2019 · cited 59× · PMID 31089248 · DOI 10.1038/s41375-019-0483-z
3. Genomic heterogeneity in core-binding factor acute myeloid leukemia and its clinical implication.
   Jahn N, Terzer T, Sträng E, Dolnik A, et al · · 2020 · cited 57× · PMID 33351131 · DOI 10.1182/bloodadvances.2020002673
4. Deregulated expression of circular RNAs in acute myeloid leukemia.
   Lux S, Blätte TJ, Gillissen B, Richter A, et al · · 2021 · cited 32× · PMID 33683343 · DOI 10.1182/bloodadvances.2020003230
5. <i>Protein phosphatase 4 regulatory subunit 2 (PPP4R2)</i> is recurrently deleted in acute myeloid leukemia and required for efficient DNA double strand break repair.
   Herzig JK, Bullinger L, Tasdogan A, Zimmermann P, et al · · 2017 · cited 11× · PMID 29221109 · DOI 10.18632/oncotarget.21119
6. MRD as Biomarker for Response to Donor Lymphocyte Infusion after Allogeneic Hematopoietic Cell Transplantation in Patients with AML.
   Teich K, Stadler M, Gabdoulline R, Kandarp J, et al · · 2023 · cited 5× · PMID 37568726 · DOI 10.3390/cancers15153911
7. Refinement of the prognostic impact of somatic <i>CEBPA</i> bZIP domain mutations in acute myeloid leukemia: Results of the AML Study Group (AMLSG).
   Rücker FG, Corbacioglu A, Krzykalla J, Cocciardi S, et al · · 2024 · cited 4× · PMID 39011127 · DOI 10.1002/hem3.123
8. Cell-free DNA for detection and monitoring of extramedullary AML relapse.
   Hupe HC, Wienecke CP, Bartels S, Schipper E, et al · · 2025 · cited 2× · PMID 40066001 · DOI 10.1002/hem3.70097