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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by University of Ulm
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Hartmut Doehner, University of Ulm
ClinicalTrials.gov Identifier:
NCT01252485
First received: December 2, 2010
Last updated: September 9, 2016
Last verified: September 2016
  Purpose

This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms

Investigator's sites: 60-70 sites in Germany and Austria

Estimated duration of observation of an individual patient:

10 years maximum

Objectives

  • To register all patients with acute myeloid leukemia and related precursor neoplasms, acute leukemia of unambiguous lineage, with higher risk myelodysplastic syndromes (MDS with excess blasts 2), and with myeloid neoplasms with germline predisposition, newly diagnosed or relapsed/refractory in all participating centers (completeness)
  • To perform timely analyses of disease-related genetic markers (incidences, treatment recommendations)
  • To assess patient and family history, clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • 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, buccal swap, finger nails, hairs, or sputum)
  • To assess quality of life

Condition
Acute Myeloid Leukemia (AML)
Higher Risk Myelodysplastic Syndromes (MDS With Excess Blasts 2)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Higher Risk Myelodysplastic Syndrome - The Biology and Outcome (BiO)-Project

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • incidence of disease-related genetic markers [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)

  • Event-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)

  • quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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) initially, in first CR, one year, 3 and 5 years after initial diagnosis.

  • Geographical representation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Geographical representation of patients through collection of patients zip codes


Study Start Date: July 2010
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with newly diagnosed or relapsed/refractory AML in all AMLSG participating centers (60-70 centers in Germany and Austria)
Criteria

Inclusion Criteria:

  • Patients with suspected diagnosis of AML and related precursor neoplasms, acute leukemias of ambiguous lineages, higher risk MDS (MDS with excess blasts 2 [MDS-EB2]), and myeloid neoplasm with germline predisposition, newly diagnosed or relapsed/refractory, classified according to the World Health Organization (WHO) 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252485

Contacts
Contact: Hartmut Döhner, Prof. Dr. 49-731-500-45501 hartmut.doehner@uniklinik-ulm.de

  Show 69 Study Locations
Sponsors and Collaborators
University of Ulm
Investigators
Study Chair: Hartmut Döhner, Prof. Dr. University Hospital of Ulm
  More Information

Responsible Party: Prof. Dr. Hartmut Doehner, Prof. Dr., University of Ulm
ClinicalTrials.gov Identifier: NCT01252485     History of Changes
Other Study ID Numbers: AMLSG BiO 
Study First Received: December 2, 2010
Last Updated: September 9, 2016
Health Authority: Germany: Registry Study -> no responsible oversight authority

Keywords provided by University of Ulm:
AML
Registry study
Biology and Outcome
Higher Risk MDS

Additional relevant MeSH terms:
Leukemia
Syndrome
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on December 02, 2016