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

Conditions

Acute Myeloid Leukemia (AML)

Brief summary

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

Desireé Kunadt, Sven Zukunft, Klaus H. Metzeler, Christoph Röllig, Christoph Schliemann et al. (32 authors)

Blood2023-11-02

10.1182/blood-2023-187273

Venetoclax-Based Salvage Therapy Improves Outcome in Relapsed/Refractory AML Patients Eligible for Intensive Treatment: A Propensity Score Matching Analysis

Julia M. Unglaub, Richard F. Schlenk, Maher Hanoun, Hans Christian Reinhardt, Jan Moritz Middeke et al. (36 authors)

Blood2022-11-15

10.1182/blood-2022-167677

Intensified cytarabine dose during consolidation in adult AML patients under 65 years is not associated with survival benefit: real-world data from the German SAL-AML registry.

Hanoun M, Ruhnke L, Kramer M, Hanoun C, Schäfer-Eckart K, Steffen B, Sauer T, Krause SW, Schliemann C, Mikesch JH, Kaufmann M, Hänel M, Jost E, Brümmendorf TH, Fransecky L, Kraus S, Einsele H, Niemann D, Neubauer A, Kullmer J, Seggewiss-Bernhard R, Görner M, Held G, Kaiser U, Scholl S, Hochhaus A, Reinhardt HC, Platzbecker U, Baldus CD, Müller-Tidow C, Bornhäuser M, Serve H, Röllig C, Study Alliance Leukemia (SAL).

2022-09-285 citations

10.1007/s00432-022-04356-9

Venetoclax-Azacitidine As Salvage Therapy and Bridge to Allogeneic Cell Transplantation in Relapsed/Refractory AML Compared to Historical Data of the SAL Registry Study

Julia M. Unglaub, Richard F. Schlenk, Maher Hanoun, Hans Christian Reinhardt, Jan Moritz Middeke et al. (36 authors)

Blood2021-11-054 citations

10.1182/blood-2021-151287

Does time from diagnosis to treatment affect the prognosis of patients with newly diagnosed acute myeloid leukemia?

Christoph Röllig, Michael Krämer, Christoph Schliemann, Jan‐Henrik Mikesch, Björn Steffen et al. (42 authors)

Blood2020-06-04133 citations

10.1182/blood.2019004583

Time from Diagnosis to Treatment Does Not Affect Outcome in Intensively Treated Patients with Newly Diagnosed Acute Myeloid Leukemia

Christoph Röllig, Michael Krämer, Christoph Schliemann, Jan-Henrik Mikesch, Björn Steffen et al. (42 authors)

Blood2019-11-1318 citations

10.1182/blood-2019-123717

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Complete Remission (CR)	yearly follow up 10 years	Complete Remission
Treatment related mortality (TRM)	yearly follow up 10 years	Treatment related mortality
Therapy-associated morbidity	yearly follow up 10 years	grade IV toxicities
Recording and evaluating the quality of therapy and diagnosis	10 years	Recording and evaluating the quality of therapy and diagnosis
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
Recording and describing new forms of therapy and new supportive measures	10 years	Recording and describing new forms of therapy and new supportive measures

Countries

Germany

Contacts

CONTACTChristoph Röllig, Prof. Dr.

christoph.roellig@uniklinikum-dresden.de

STUDY_DIRECTORChristoph Röllig, Prof. Dr.

Universitätsklinikum Carl Gustav Carus

Outcome results