Long-term Outcomes for Acute Myeloid Leukemia Patients

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT03755856
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary

This international observational study aims at examining the patterns of health-related quality of life differences between long-term acute myeloid leukemia patients and their healthy peers from the general population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-28
• Study Start: 2019-05-16
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04
• Primary Completion: 2021-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 343

Inclusion Criteria

• Diagnosis of all subtypes of de novo AML, according to WHO criteria (at least 20% blasts in the bone marrow), except acute promyelocytic leukemia (APL).
• Age at AML diagnosis ≥ 18 years,
• Date of AML diagnosis at least 5 years before study enrollment,
• AML-free status at study enrollment,
• Written informed consent provided.

Exclusion Criteria

• Major cognitive deficit or psychiatric problems hampering a self-reported evaluation,
• Not speaking and reading the language of the participating country,
• More than 75 years at the time of study enrollment,
• Receiving any active treatment for AML at the time of study enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of differences in SF-36 scores	At enrollment	The Role Physical scores of AML survivors will be compared to that in the general population as assessed by SF-36 questionnaire. Comparisons will be performed on age-sex matched pairs of AML patients and healthy subjects from the general population.

Secondary Outcome Measures

Name	Time	Method
Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.	At enrollment	Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores
Outcomes from SCQ questionnaire will be described and compared between AML patients from RCTs vs non RCTs.	At enrollment	Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores.
Outcomes from EORTC QLQ-C30 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.	At enrollment	Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores.
QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire.	At enrollment	Comparisons will be adjusted by age and sex, using the European reference values for the EORTC QLQ-C30. A subgroup analysis on elderly patients (i.e. 60+ patients) will be also performed.

Trial Locations

Locations (39)

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

CHR Citadelle-CHU; 🇧🇪 Liège, Belgium

University of Liège; 🇧🇪 Liège, Belgium

KBC Rijeka; 🇭🇷 Rijeka, Croatia

University Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia

Les Hôpitaux Universitaires de Strasbourg; 🇫🇷 Lyon, France

Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI; 🇮🇹 Ancona, Italy

U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari; 🇮🇹 Bari, Italy

UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"; 🇮🇹 Barletta, Italy

Divisione di Ematologia Ospedale A. Perrino; 🇮🇹 Brindisi, Italy

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