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NCT Number: NCT03188874

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

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

Investigator's sites: 60 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

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Mittelbaden, Baden-Baden, Baden-Wurttemberg, Germany

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About this study

see brief summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Christoph Röllig, Prof. Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Important dates

Study start
2010
Primary completion
2030
Study completion
2030
First posted
Jun 16, 2017
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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