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

Condition(s) studied

Study 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)

Eligibility

Primary outcome measure(s)

• 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

Trial sites (94)

+ 54 more sites — see the full list on the official registry below.

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