Acute Myeloid Leukemia1621-QLG-LGNCT03755856
Long-term Outcomes for Acute Myeloid Leukemia Patients
An observational study of Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 39 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Questionnaire
- How many people
- 343 participants
- Where
- 39 sitesin 8 countries
- Study dates
- 16 May 2019to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study patients are acute myeloid leukemia long-term survivors
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 8 countries.
39 sites in 8 countries
Italy29 sites, 29 recruiting
- Recruiting
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
Ancona
Attilio Olivieri
Attilio Olivieri
- Recruiting
U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari
Bari
Francesco Albano
Francesco Albano
- Not yet recruiting
UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"
Barletta
Giuseppe Tarantini
Giuseppe Tarantini
- Recruiting
Divisione di Ematologia Ospedale A. Perrino
Brindisi
Domenico Pastore
Domenico Pastore
- Not yet recruiting
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Cagliari
Claudio Romani
Claudio Romani
- Recruiting
Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto
Catania
Francesco Di Raimondo
Francesco Di Raimondo
- Recruiting
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Cona
Maria Ciccone
Maria Ciccone
- Recruiting
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
Foggia
Silvana Franca Capalbo
Franca Capalbo
- Recruiting
IRCCS_AOU San Martino-IST.Clinica Ematologica
Genova
Roberto Massimo Lemoli
Roberto Massimo Lemoli
- Recruiting
Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Milan
Nicola Fracchiolla
Nicola Fracchiolla
- Recruiting
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Naples
Fabrizio Pane
Fabrizio Pane
- Not yet recruiting
UOC di Ematologia-Centro Emofilia e Trombosi - Ospedale Ascalesi - ASL Napoli 1
Naples
Angiolina Rocino
Angiolina Roccino
- Not yet recruiting
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara
Monia Lunghi
Monia Lunghi
- Not yet recruiting
Orbassano Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
Orbassano
Daniela Cilloni
Daniela Cilloni
- Not yet recruiting
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Padova
Carmela Gurrieri
Carmela Gurrieri
- Recruiting
U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone"
Palermo
Maria Enza Mitra
Maria Enza Mitra
- Recruiting
U.O. Ematologia e CTMO- AOU di Parma
Parma
Monica Cugnola
Monica Cugnola
- Recruiting
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
Piacenza
Daniele Vallisa
Daniele Vallisa
- Recruiting
Ematologia - Ospedale San Carlo
Potenza
Nunzio Filardi
Nunzio Filardi
- Recruiting
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia
Imovilli Annalisa
Imovilli Annalisa
- Recruiting
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma
Agostino Tafuri
Agostino Tafuri
- Recruiting
Divisione di Ematologia - Ospedale S.Eugenio
Roma
Paolo De Fabritiis
Paolo De Fabritiis
- Recruiting
Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)
Roma
Luca Maurillo
Luca Maurillo
- Recruiting
Istituto di Semeiotica Medica - Ematologia - Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
Simona Sica
Simona Sica
- Recruiting
Roma Divisione Ematologia - Università Campus Bio-Medico
Roma
Giuseppe Avvisati
Giuseppe Avvisati
- Recruiting
Università degli Studi "Sapienza" - Dip Medicina di Precisione e Ricerca Traslazionale UOC Ematologia
Roma
Maurizio Martelli
Maurizio Martelli
- Recruiting
U.O. di Ematologia - Casa Sollievo della Sofferenza
San Giovanni Rotondo
Nicola Cascavilla
Nicola Cascavilla
- Recruiting
Ematologia - AOU Sassari
Sassari
Claudio Fozza
Claudio Fozza
- Recruiting
Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Torino
Ernesta Audisio
Ernesta Audisio
Belgium3 sites, 3 recruiting
- Not yet recruiting
UZ Gasthuisberg
Leuven
Johan Maertens
Johan Maertens
- Not yet recruiting
CHR Citadelle-CHU
Liège
Aurélie Jaspers
Aurélie Jaspers
- Not yet recruiting
University of Liège
Liège
Frédéric Baron
Frédéric Baron
Croatia2 sites, 2 recruiting
- Not yet recruiting
KBC Rijeka
Rijeka
Duska Petranovic
Dusca Petranovic
- Not yet recruiting
University Hospital Centre Zagreb
Zagreb
Radovan Petranovic
Radovan Petranovic
France1 site, 1 recruiting
- Not yet recruiting
Les Hôpitaux Universitaires de Strasbourg
Lyon
Xavier Thomas
Xavier Thomas
North Macedonia1 site, 1 recruiting
- Not yet recruiting
University Clinic of Hematology-Skopje
Skopje
Irina Panovska
Irina Panovska
Slovakia1 site, 1 recruiting
- Not yet recruiting
University hospital Bratislava
Bratislava
Martin Mistrik
Martin Mistrik
Slovenia1 site, 1 recruiting
- Not yet recruiting
UKC Ljubljana
Ljubljana
Matevz Skerget
Matevz Skerget
Turkey (Türkiye)1 site, 1 recruiting
- Not yet recruiting
Ankara University School Of Medicine Cebeci Campus Adult Hematology Department and BMT Unit
Ankara
Maltem Yuksel
Maltem Yuksel
About this study
Official title: A Survivorship Project to UnerstAnd and to impRove Long-Term Outcomes for Acute Myeloid Leukemia Patients (SPARTA): the Sparta Platform
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Questionnaire
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Health-related quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Secondary outcomes (4)
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
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start16 May 2019
- Primary completionJun 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 343 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Efficace, Study chair, GIMEMA FoundationFrédéric Baron, Study director, European Organisation for Research and Treatment of Cancer - EORTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755856
- Sponsor's protocol ID
- GIMEMA-EORTC 1621-QLG-LG
- Acronym
- 1621-QLG-LG
- Status last verified
- Mar 2020
- First submitted
- 26 Nov 2018
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survivorship Project to UnerstAnd and to impRove Long-Term Outcomes for Acute Myeloid Leukemia Patients (SPARTA): the Sparta Platform
- ClinicalTrials.gov ID
- NCT03755856
- Acronym / sponsor ID
- 1621-QLG-LG / GIMEMA-EORTC 1621-QLG-LG
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 343 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
- Study start
- 16 May 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study patients are acute myeloid leukemia long-term survivors
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireHealth-related quality of life | Other | – |
Primary outcome
Number of differences in SF-36 scores
Time frame: 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.
4 secondary outcomes
Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
Time frame: At enrollment
QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire.
Time frame: At enrollment
Outcomes from SCQ questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
Time frame: At enrollment
Outcomes from EORTC QLQ-C30 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Efficace study chair
GIMEMA Foundation
Frédéric Baron study director
European Organisation for Research and Treatment of Cancer - EORTC
39 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 39 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Italy, Belgium, Croatia, France, North Macedonia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca Tartaglia (+39 06 441639837, f.tartaglia@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of differences in SF-36 scores (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.