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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTechnische Universität Dresden

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

there are no exclusion criteria

Trial population

Patients with newly-diagnosed AML, including acute promyelocytic leukemia (APL)

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Epidemiological parameters

Epidemiological parameters

Time frame
10 years
2

Relapse free survival (RFS)

Relapse free survival

Time frame
10 years
3

Time to relapse (TTR),

Time to relapse (TTR),

Time frame
10 years
4

Overall Survival (OS)

Overall Survival (OS)

Time frame
10 years

Secondary outcomes

1

Complete Remission (CR)

Complete Remission

Time frame
yearly follow up 10 years
2

Treatment related mortality (TRM)

Treatment related mortality

Time frame
yearly follow up 10 years
3

Therapy-associated morbidity

grade IV toxicities

Time frame
yearly follow up 10 years
4

Recording and evaluating the quality of therapy and diagnosis

Recording and evaluating the quality of therapy and diagnosis

Time frame
10 years

Other outcomes

Sponsors and contacts

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