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Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)

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ClinicalTrials.gov Identifier: NCT03188874
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Brief Summary:

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

Investigator's sites: 40 sites in Germany.

Primary objectives:

  • Identification of epidemiological data on AML: age, prognostic factors and subgroup distributions. Incidence and age distribution are compared with the data of population-related tumor registry.
  • Evaluation of the most important patient-relevant clinical endpoints (outcomes): relapse-free survival (RFS) / time to relapse (TTR), calculation of cumulative incidence of relapse (CIR) and overall survival (OS)
  • Documentation of treatment strategy

Condition or disease
Acute Myeloid Leukemia (AML)

Detailed Description:
see brief summary

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
Study Start Date : September 2010
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025





Primary Outcome Measures :
  1. Epidemiological parameters [ Time Frame: 10 years ]
    Epidemiological parameters

  2. Relapse free survival (RFS) [ Time Frame: 10 years ]
    Relapse free survival

  3. Time to relapse (TTR), [ Time Frame: 10 years ]
    Time to relapse (TTR),

  4. Overall Survival (OS) [ Time Frame: 10 years ]
    Overall Survival (OS)

  5. cumulative incidence of relapse (CIR) [ Time Frame: 10 years ]
    cumulative incidence of relapse (CIR)


Secondary Outcome Measures :
  1. Complete Remission (CR) [ Time Frame: yearly follow up 10 years ]
    Complete Remission

  2. Treatment related mortality (TRM) [ Time Frame: yearly follow up 10 years ]
    Treatment related mortality

  3. Therapy-associated morbidity [ Time Frame: yearly follow up 10 years ]
    grade IV toxicities

  4. Recording and evaluating the quality of therapy and diagnosis [ Time Frame: 10 years ]
    Recording and evaluating the quality of therapy and diagnosis

  5. Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors [ Time Frame: 10 years ]
    Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors

  6. Recording and describing new forms of therapy and new supportive measures [ Time Frame: 10 years ]
    Recording and describing new forms of therapy and new supportive measures


Biospecimen Retention:   Samples Without DNA
bone marrow peripher blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly-diagnosed AML, including acute promyelocytic leukemia (APL)
Criteria

Inclusion Criteria:

  • AML according to the WHO (World Health Organization) diagnostic criteria, including acute promyelocytic leukemia
  • Age ≥ 18 years. There is no upper age limit.
  • Signed written informed consent

Exclusion Criteria:

  • there are no exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188874


Contacts
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Contact: Christoph Röllig, Prof. Dr. christoph.roellig@uniklinikum-dresden.de

Locations
Show Show 43 study locations
Sponsors and Collaborators
Technische Universität Dresden
Investigators
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Study Director: Christoph Röllig, Prof. Dr. Universitätsklinikum Carl Gustav Carus
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT03188874    
Other Study ID Numbers: SAL-AML-REG-BIO
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid