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Recruiting NCT03188874

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

— Observational Acute Myeloid Leukemia (AML)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia (AML). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

see brief summary

Primary outcome measures

  • Epidemiological parameters [Time frame: 10 years]
  • Relapse free survival (RFS) [Time frame: 10 years]
  • Time to relapse (TTR), [Time frame: 10 years]
  • Overall Survival (OS) [Time frame: 10 years]
  • cumulative incidence of relapse (CIR) [Time frame: 10 years]
Secondary outcome measures (6)
  • Complete Remission (CR) [Time frame: yearly follow up 10 years]
  • Treatment related mortality (TRM) [Time frame: yearly follow up 10 years]
  • Therapy-associated morbidity [Time frame: yearly follow up 10 years]
  • Recording and evaluating the quality of therapy and diagnosis [Time frame: 10 years]
  • Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors [Time frame: 10 years]
  • Recording and describing new forms of therapy and new supportive measures [Time frame: 10 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Germany · 60 centers
  • Klinikum Mittelbaden — Baden-Baden
  • Universtitätsklinikum Heidelberg — Heidelberg
  • Klinikum Mannheim GmbH — Mannheim
  • Diakonie-Klinikum — Schwäbisch Hall
  • Kliniken Sindelfingen-Böblingen gGmbH — Sindelfingen
  • Robert-Bosch-Krankenhaus GmbH — Stuttgart
  • Rems-Murr-Klinikum Winnenden — Winnenden
  • Klinikum Augsburg — Augsburg
  • … and 52 more centers

Publications

  • Hanoun M, Ruhnke L, Kramer M, Hanoun C, Schafer-Eckart K, Steffen B, Sauer T, Krause SW, Schliemann C, Mikesch JH, Kaufmann M, Hanel M, Jost E, Brummendorf TH, Fransecky L, Kraus S, Einsele H, Niemann D, Neubauer A, Kullmer J, Seggewiss-Bernhard R, Gorner M, Held G, Kaiser U, Scholl S, Hochhaus A, Reinhardt HC, Platzbecker U, Baldus CD, Muller-Tidow C, Bornhauser M, Serve H, Rollig C; Study Allian PMID 36167894
  • Kunadt D, Stasik S, Metzeler KH, Rollig C, Schliemann C, Greif PA, Spiekermann K, Rothenberg-Thurley M, Krug U, Braess J, Kramer A, Hochhaus A, Scholl S, Hilgendorf I, Brummendorf TH, Jost E, Steffen B, Bug G, Einsele H, Gorlich D, Sauerland C, Schafer-Eckart K, Krause SW, Hanel M, Hanoun M, Kaufmann M, Wormann B, Kramer M, Sockel K, Egger-Heidrich K, Herold T, Ehninger G, Burchert A, Platzbecker PMID 36064577
  • Rollig C, Kramer M, Schliemann C, Mikesch JH, Steffen B, Kramer A, Noppeney R, Schafer-Eckart K, Krause SW, Hanel M, Herbst R, Kunzmann V, Einsele H, Jost E, Brummendorf TH, Scholl S, Hochhaus A, Neubauer A, Sohlbach K, Fransecky L, Kaufmann M, Niemann D, Schaich M, Frickhofen N, Kiani A, Heits F, Krumpelmann U, Kaiser U, Kullmer J, Wass M, Stolzel F, von Bonin M, Middeke JM, Thiede C, Schetelig J PMID 32496541

Identifiers

NCT: NCT03188874 · SAL-AML-REG-BIO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗