Quality of life, Survival, COmorbidities, and Pharmacoeconomics in Elderly patients with Acute Myeloid Leukemia

Quality of life, Survival, COmorbidities, and Pharmacoeconomics in Elderly patients with Acute Myeloid Leukemia - QSCOPE-AML

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53259

Enrollment

100

Registered

2023-08-07

Start date

2023-10-17

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Bloodcancer Leukeamia

Interventions

None listed

Eligibility

Age

65 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patient is diagnosed with de novo AML [ICD-10 = C92] • Patient is treated in the Medical Centre Leeuwarden • Age upon diagnosis >= 65 years • Patient is classified as *ineligible for intensive chemotherapy* by the list 1 of the Ferrara criteria or by consideration from the practising haematologist • Patient receives treatment in the form of a HMA combination regimen • Patient provides a signed Informed Consent Form

Exclusion criteria

Exclusion criteria: • Bonemarrow analysis did not confirm AML • Patients diagnosed with APL (t(15;17), WHO 2016) [ICD-10 = C92.4] • Patients diagnosed with AMML (AML M4 / AML-M4eos) [ICD-10 = C92.5] • Patients diagnosed with AMBL/AMCL (AML M5 / M5a / M5b) [ICD-10 = C93]

Design outcomes

Primary

Measure	Time frame
Primary Objective: • To assess how the quality of life develops throughout a patients journey in an unselected real-world population of AML patients treated with HMA combination regimens	—

Secondary

Measure	Time frame
Secondary Objectives: • To assess overall survival of AML patients treated with HMA combination regimens in an unselected real-world population • To calculate remission (CR/CRi/PR) rates • To calculate event free survival (time between CR and progression of disease PD) • To calculate rates of early death (ED, death within 30 days after diagnosis) • To quantify healthcare usage (length of hospital stay, number of bonemarrow analysis, amount of transfusion usage, number of days under anti-infective treatment) • To evaluate HMA combination regimens pharmaco-economically by calculating gained QALYs, price per gained QALY, and the ICER of the combination regimens compared against HMA monotherapy Exploratory Objectives: • To explore and describe how frail unselected real-world AML patients are at diagnosis using geriatric screening tools (G-8, 6CIT) and comorbidity tools (HCT-CI, AML-CM, Ferrara criteria lists, Wheatley Index, Charlson Comorbidity Index CCI) • To explore which baseline characteristics such as patient priorities and results of clinical scoring tools (Ferrara, Wheatley, HCT-CI, AML-CM) predict overall survival, 1-year survival, remission rates, rates of treatment related mortality, and rates of ED best • To explore how much time patients spend in the hospital (planned / unplanned, during first 2 cycles / during rest of treatment trajectory, under various regimens)	—

Measure

Time frame

Secondary Objectives: • To assess overall survival of AML patients treated with HMA combination regimens in an unselected real-world population • To calculate remission (CR/CRi/PR) rates • To calculate event free survival (time between CR and progression of disease PD) • To calculate rates of early death (ED, death within 30 days after diagnosis) • To quantify healthcare usage (length of hospital stay, number of bonemarrow analysis, amount of transfusion usage, number of days under anti-infective treatment) • To evaluate HMA combination regimens pharmaco-economically by calculating gained QALYs, price per gained QALY, and the ICER of the combination regimens compared against HMA monotherapy Exploratory Objectives: • To explore and describe how frail unselected real-world AML patients are at diagnosis using geriatric screening tools (G-8, 6CIT) and comorbidity tools (HCT-CI, AML-CM, Ferrara criteria lists, Wheatley Index, Charlson Comorbidity Index CCI) • To explore which baseline characteristics such as patient priorities and results of clinical scoring tools (Ferrara, Wheatley, HCT-CI, AML-CM) predict overall survival, 1-year survival, remission rates, rates of treatment related mortality, and rates of ED best • To explore how much time patients spend in the hospital (planned / unplanned, during first 2 cycles / during rest of treatment trajectory, under various regimens)

—

Countries

Netherlands

Outcome results