Quality of life and late effects in leukemia survivors

Quality of life and late effects in leukemia survivors - AML SURVIVORSHIP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023991

Enrollment

400

Registered

2021-01-06

Start date

2017-12-10

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia+ C92.0 C92.5 C92.6 C92.3 C93.0 C94.0 C94.2

Interventions

Group 1: Patients who suffered from acute myeloid leukemia (AML) and were enrolled into a treatment trial or the patient registry of the German AML Cooperative Group AML-CG, and who are alive =5 years

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients suffering from acute myeloid leukemia (AML) who were enrolled into the patient registry of the German AML Cooperative Group (AML-CG, DRKS00020816) and/or one of the following interventional trials: AMLCG-1999 (clinicaltrials.gov NCT00266136), AMLCG-2004 (European Leukemia Trial Registry Nr. LN_AMLINT_2004_230), AMLCG-2008 (clinicaltrials.gov NCT01382147). - Study participants have survived =5 years from initial diagnosis off AML.

Exclusion criteria

Exclusion criteria: - Current leukemia relapse - Age <18 years - Inability to give valid informed consent - Insufficient german language proficiency which makes the participant unable to answer the study questionnaires

Design outcomes

Primary

Measure	Time frame
Primary endpoint of this study is a comparison of quality of life (QoL) and general and health-related life satisfaction (LS) in AML survivors, compared to an age- and sex-matched healthy control cohort. QoL and LS will be measured using the FACT-G and FLZ-A/G questionnaires, respectively. We will use a graph-based sequential testing procedure to control for multiple testing of the co-primary endpoints (Bretz F et al., Stat Med 2009; 28:586).	—

Measure

Time frame

Primary endpoint of this study is a comparison of quality of life (QoL) and general and health-related life satisfaction (LS) in AML survivors, compared to an age- and sex-matched healthy control cohort. QoL and LS will be measured using the FACT-G and FLZ-A/G questionnaires, respectively. We will use a graph-based sequential testing procedure to control for multiple testing of the co-primary endpoints (Bretz F et al., Stat Med 2009; 28:586).

—

Secondary

Measure	Time frame
- Frequency of clonal hematopoiesis in AML long-term survivors - Medical, psycho-social and demographic factors associated with an increased risk of somatic or psychological health problems in AML survivors - Associations between clonal hematopoiesis and somatic morbidity in AML survivors	—

Countries

Germany

Contacts

Public ContactEva Telzerow

Medizinische Klinik und Poliklinik IIIKlinikum der Universität München

eva.telzerow@med.uni-muenchen.de089 / 4400–74919

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026