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

Study acronym: AMLSG BiO
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 93 to 94v30
  2. Study sites: 91 to 93v29
  3. Study sites: 90 to 91v28
  4. Site contacts updated at 1 of 90 sitesv27
  5. Site contacts updated at 1 of 90 sitesv26
Show 24 earlier versionsHide 24 earlier versions
  1. Site contacts updated at 1 of 90 sitesv25
  2. Site details revised at 1 of 90 sitesv24
  3. Site contacts updated at 1 of 90 sitesv23
  4. Site contacts updated at 1 of 90 sitesv22
  5. Site contacts updated at 1 of 90 sitesv21
  6. Site contacts updated at 1 of 90 sitesv20
  7. Primary endpoints: 8 to 11
    • Eligibility criteria shortened, about 21 words
    • Study title shortened, about 5 words
    v19
  8. Site contacts updated at 1 of 90 sitesv18
  9. Enrollment target: 50000
    • Primary and study completion dates: Dec 31, 2044
    • Start date: Jul 2010 to Jul 6, 2010
    • Site contacts updated at 1 of 90 sites
    v17
  10. Study sites: 84 to 90v16
  11. Site details revised at 7 of 84 sitesv15
  12. Re-verified, no change to tracked fieldsv14
  13. Study sites: 76 to 84v13
  14. Study sites: 70 to 76v12
  15. Site contacts updated at 1 of 70 sitesv11
  16. Re-verified, no change to tracked fieldsv10
  17. Study sites: 69 to 70v9
  18. Primary endpoints revised (8)
    • Study sites: 1 to 69
    • Study title revised
    • Eligibility criteria shortened, about 4 words
    v8
  19. 6 versions Re-verified since Oct 13, 2011, no change to tracked fieldsv2-v7
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT01252485
Lead Sponsor University of Ulm
Conditions
(from sponsor)		 Acute Myeloid Leukemia (AML), MDS/AML
Related terms Leukemia, Myeloid, Acute
Enrollment 50,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov