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

Recruiting

• Conditions: Acute Myeloid Leukemia (AML)

• Registration Number: NCT03188874
• Lead Sponsor: 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: 51 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

Detailed Description

see brief summary

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18
• Primary Completion: 2030-09-30
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidemiological parameters	10 years	Epidemiological parameters
Relapse free survival (RFS)	10 years	Relapse free survival
Overall Survival (OS)	10 years	Overall Survival (OS)
Time to relapse (TTR),	10 years	Time to relapse (TTR),
cumulative incidence of relapse (CIR)	10 years	cumulative incidence of relapse (CIR)

Secondary Outcome Measures

Name	Time	Method
Recording and describing new forms of therapy and new supportive measures	10 years	Recording and describing new forms of therapy and new supportive measures
Complete Remission (CR)	yearly follow up 10 years	Complete Remission
Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors	10 years	Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors
Therapy-associated morbidity	yearly follow up 10 years	grade IV toxicities
Treatment related mortality (TRM)	yearly follow up 10 years	Treatment related mortality
Recording and evaluating the quality of therapy and diagnosis	10 years	Recording and evaluating the quality of therapy and diagnosis

Trial Locations

Locations (51)

Klinikum Mittelbaden; 🇩🇪 Baden-Baden, Baden-Württemberg, Germany

Universtitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

Klinikum Mannheim GmbH; 🇩🇪 Mannheim, Baden-Württemberg, Germany

Diakonie-Klinikum; 🇩🇪 Schwäbisch Hall, Baden-Württemberg, Germany

Kliniken Sindelfingen-Böblingen gGmbH; 🇩🇪 Sindelfingen, Baden-Württemberg, Germany

Robert-Bosch-Krankenhaus GmbH; 🇩🇪 Stuttgart, Baden-Württemberg, Germany

Rems-Murr-Klinikum Winnenden; 🇩🇪 Winnenden, Baden-Württemberg, Germany

Klinikum Augsburg; 🇩🇪 Augsburg, Bayern, Germany

Sozialstiftung Bamberg; 🇩🇪 Bamberg, Bayern, Germany

Klinikum Bayreuth GmbH; 🇩🇪 Bayreuth, Bayern, Germany

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