Long-term Outcomes for Acute Myeloid Leukemia Patients

Acute Myeloid Leukemia Clinical Trial

— 1621-QLG-LG  

Official title:

A Survivorship Project to UnerstAnd and to impRove Long-Term Outcomes for Acute Myeloid Leukemia Patients (SPARTA): the Sparta Platform

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03755856
• Other study ID #: GIMEMA-EORTC 1621-QLG-LG
• Status: Recruiting
• Start date: May 16, 2019
• Est. completion date: December 2022

Study information

• Verified date: March 2020
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Francesca Tartaglia
• Phone: +39 06 441639837
• Email: f.tartaglia[@]gimema.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 343
• Est. completion date: December 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• Questionnaire
Health-related quality of life

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg	Leuven
Belgium	CHR Citadelle-CHU	Liège
Belgium	University of Liège	Liège
Croatia	KBC Rijeka	Rijeka
Croatia	University Hospital Centre Zagreb	Zagreb
France	Les Hôpitaux Universitaires de Strasbourg	Lyon
Italy	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	ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO	Cagliari
Italy	Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto	Catania
Italy	Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi	Cona
Italy	Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria	Foggia
Italy	IRCCS_AOU San Martino-IST.Clinica Ematologica	Genova
Italy	Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano	Milano
Italy	Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia	Napoli
Italy	UOC di Ematologia-Centro Emofilia e Trombosi - Ospedale Ascalesi - ASL Napoli 1	Napoli
Italy	S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro	Novara
Italy	Orbassano Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2	Orbassano
Italy	Università degli Studi di Padova - Ematologia ed Immunologia Clinica	Padova
Italy	U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone"	Palermo
Italy	U.O. Ematologia e CTMO- AOU di Parma	Parma
Italy	Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto	Piacenza
Italy	Ematologia - Ospedale San Carlo	Potenza
Italy	Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova	Reggio Emilia
Italy	Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia	Roma
Italy	Divisione di Ematologia - Ospedale S.Eugenio	Roma
Italy	Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)	Roma
Italy	Istituto di Semeiotica Medica - Ematologia - Università Cattolica del Sacro Cuore - Policlinico A. Gemelli	Roma
Italy	Roma Divisione Ematologia - Università Campus Bio-Medico	Roma
Italy	Università degli Studi "Sapienza" - Dip Medicina di Precisione e Ricerca Traslazionale UOC Ematologia	Roma
Italy	U.O. di Ematologia - Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	Ematologia - AOU Sassari	Sassari
Italy	Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista	Torino
North Macedonia	University Clinic of Hematology-Skopje	Skopje
Slovakia	University hospital Bratislava	Bratislava
Slovenia	UKC Ljubljana	Ljubljana
Turkey	Ankara University School Of Medicine Cebeci Campus Adult Hematology Department and BMT Unit	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto	European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Croatia,  France,  Italy,  North Macedonia,  Slovakia,  Slovenia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of differences in SF-36 scores	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.	At enrollment
Secondary	Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.	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	At enrollment
Secondary	QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire.	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.	At enrollment
Secondary	Outcomes from SCQ questionnaire will be described and compared between AML patients from RCTs vs non RCTs.	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.	At enrollment
Secondary	Outcomes from EORTC QLQ-C30 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.	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.	At enrollment