Assessing Overall Survival, Quality of Life, Frailty, Comorbidity Indexes, Healthcare Usage, and Pharmacoeconomics in Elderly Patients with Acute Myeloid Leukemia

Withdrawn

Conditions: AML
bloodcancer
10024324

Registration Number: NL-OMON51315

Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Patients in the Dutch province of Friesland may present at any of the 4 Frisian
Hospitals. Complicated cases such as elderly patients with AML are referred to
the MCL. Patients from outside of the province of Friesland are uncommon.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Age upon diagnosis <= 65 years
• Patients diagnosed with APL (t(15;17), WHO 2016)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Quality of Life reported by patient<br /><br>• Overall survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Rate of Complete Remission or Complete Remission with incomplete count<br /><br>recovery CR/CRi<br /><br>• Early Death (30-day mortality)<br /><br>• Ferrara Criteria treatment advice<br /><br>• Wheatley Score<br /><br>• HCT-CI Score<br /><br>• AML-CM Score<br /><br>• ECOG Performance Status<br /><br>• Cytogenetica / molecular risk profile<br /><br>• ELN classification<br /><br>• Other parameters necessary for scoring such as eGFR, LDH, RBC, BMI, Albumine,<br /><br>Serum Creatinine<br /><br>• Treatment regimen as per 2 weeks after diagnosis<br /><br>• Healthcare usage such as antibiotic prescription events or receiving blood<br /><br>transfusion<br /><br>• Quality of Life as reported posthumous by relatives<br /><br><br /><br>A complete list of datapoints collected and how they will be formatted in our<br /><br>research database can be found in the excel file Databasestructure<br /><br>ZEALOUS-AML.</p><br>