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

Conditions

Acute Myeloid Leukemia (AML), MDS/AML

Keywords

AML, Registry study, Biology and Outcome, MDS/AML

Brief summary

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)

Frank G. Rücker, Andrea Corbacioglu, Julia Krzykalla, Sibylle Cocciardi, Claudia Lengerke et al. (27 authors)

HemaSphere2024-07-014 citations

10.1002/hem3.123

P448: PROGNOSTIC IMPACT OF SOMATIC CEBPA BZIP DOMAIN MUTATIONS IN ACUTE MYELOID LEUKEMIA

F. Ruecker, A Corbacioglu, Frauke Theis, M. Christopeit, Ulrich Germing et al. (23 authors)

HemaSphere2022-06-011 citations

10.1097/01.hs9.0000844680.77570.26

Ivosidenib Improves Overall Survival Relative to Standard Therapies in Relapsed or Refractory Mutant <i>IDH1</i> AML: Results from Matched Comparisons to Historical Controls

Peter Paschka, Hervé Dombret, Xavier Thomas, Christian Récher, Sylvain Chantepie et al. (29 authors)

Blood2020-11-053 citations

10.1182/blood-2020-136957

Assessment of the Genomic Landscape of Intermediate Risk Acute Myeloid Leukemia As Defined By 2010 ELN Risk Classification

Ekaterina Panina, Frank G. Rücker, Lars Bullinger, Anna Dolnik, Julia Herzig et al. (22 authors)

Blood2018-11-29

10.1182/blood-2018-99-114671

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, Lübbert M, Fiedler W, Kindler T, Krauter J, Brossart P, Kündgen A, Salih HR, Westermann J, Wulf G, Hertenstein B, Wattad M, Götze K, Kraemer D, Heinicke T, Girschikofsky M, Derigs HG, Horst HA, Rudolph C, Heuser M, Göhring G, Teleanu V, Bullinger L, Thol F, Gaidzik VI, Paschka P, Döhner K, Ganser A, Döhner H, Schlenk RF, German-Austrian AML Study Group (AMLSG).

2017-10-31115 citations

10.1007/s00277-017-3150-3

Impact of Age and Midostaurin-Dose on Response and Outcome in Acute Myeloid Leukemia with FLT3-ITD: Interim-Analyses of the AMLSG 16-10 Trial

Richard F. Schlenk, Walter Fiedler, Helmut R. Salih, Gerald Wulf, Felicitas Thol et al. (54 authors)

Blood2016-12-0222 citations

10.1182/blood.v128.22.449.449

Midostaurin in Combination with Intensive Induction and As Single Agent Maintenance Therapy after Consolidation Therapy with Allogeneic Hematopoietic Stem Cell Transplantation or High-Dose Cytarabine (NCT01477606)

Richard F. Schlenk, Konstanze Döhner, Helmut R. Salih, Andrea Kündgen, Walter Fiedler et al. (29 authors)

Blood2015-12-0343 citations

10.1182/blood.v126.23.322.322

An Adapted Gating Strategy Integrating a Myelomonocytic Window Is Necessary For Correct Flow Cytometric Diagnosis In a Large Proportion Of AML With Mutated NPM1

Miriam Kull, Christian Langer, Michela Tassara, Christine Schoepflin, Olena Bayer et al. (21 authors)

Blood2013-11-15

10.1182/blood.v122.21.2593.2593

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
incidence of disease-related genetic markers	4 weeks	To perform rapid analyses of disease-related genetic markers (according to International Consensus Classification 2022) (incidences, treatment recommendations)
Event-free survival	10 years	To assess patient and family history, patient characteristics and outcome data (event-free survival \[EFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \[OS\])
Cumulative incidence of relapse	10 years	To assess patient and family history, patient characteristics and outcome data (event-free survival \[EFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \[OS\])
Cumulative incidence of death	10 years	To assess patient and family history, patient characteristics and outcome data (event-free survival \[EFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \[OS\])
Overall survival	10 years	To assess patient and family history, patient characteristics and outcome data (event-free survival \[EFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \[OS\])
Treatment decision (intensive, non-intensive, investigational)	1 year	To perform rapid analyses of disease-related genetic markers (according to ICC 2022) (incidences, treatment recommendations)
quality of life	2 years	Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, socioeconomics, and demographics according to Messerer D et al (2008), 6, 12 and 24 months after registration.
Geographical representation	1 day	Geographical representation of patients through collection of patients zip codes
Response to therapy	1 year	Rate of response: complete remission (CR), CR with partial hematologic recovery (CRh); CR with incomplete hematologic recovery (CRi)
Relapse-free survival	10 years	—
Measurable residual disease (MRD)	10 years	—

Countries

Austria, Germany

Contacts

Primary ContactHartmut Döhner, Prof. Dr.

hartmut.doehner@uniklinik-ulm.de49-731-500-45501

Outcome results