Clinical Trials

The QOL-ONE Association develops and manages Multicenter National and International Clinical Trials to evaluate new treatments for patients with hematologic diseases. The clinical objectives of the studies include efficacy – in terms of response to treatment, survival and patient’s subjective measure (quality of life and symptoms -Patient Reported Outcomes) – and safety (assessment of adverse events associated with treatments). 

QOL-ONE also performs observational and translational studies. Further, it develops new instruments for the evaluation of patient-reported outcomes in hematological patients.

The trials and projects involve hematologists, patients and advocacy groups throughout the world.

QOL-ONE is technically supported by Dielnet s.r.l.  (Contract Reasearch Organization)

ONGOING CLINICAL TRIALS

QoLESS AZA-AMLEEQol MDSQOL-ONE Trans-1

QoLESS AZA-AMLE: “A Randomized Study to Evaluate the Efficacy of 5-Azacitidine for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients. ”

EudraCT Number: 2010-019710-24

https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-019710-24/IT#A

Italian, randomized, prospective, open-label, multicenter, phase III study. The aim of the study is to evaluate the effects of the therapy with the injectable azacitidine for the maintenance of complete remission in elderly patients with acute myeloid leukemia.  This disease is characterized by a scarce response to treatments and early relapses inpatients in remission, leading to a short survival.

Patients in complete remission following the conventional induction and consolidation chemotherapy treatment, are randomized for  5-Azacitidine (experimental arm)  or best supportive care (control arm).

Objective of the study are to evaluate the difference in disease-free survival (DFS), in the overall survival, in adverse events and in the in changes in QoL scores from diagnosis at 2 and 5 years between 5-Azacitidine and best supportive care arms.

Participating centers:

  • Alessandria  Azienda Ospedaliera Nazionale  SS. Antonio e Biagio e Cesare Arrigo – Divisione di Ematologia – Dr. Flavia Salvi
  • Ancona  Ospedali Riuniti di Ancona – Clinica di Ematologia – Antonella Poloni antonella.poloni@ospedaliriunitimarche.marche.it
  • Avellino  A. O. San Giovanni Moscati – Divisione di Ematologia – Dr. Antonio Volpe 
  • Bari Azienda Ospedaliera Universitaria Policlinico –Ematologia con Trapianto Universitaria- Prof.ssa Giorgina Specchia  giorgina.specchia@uniba.it
  • Catania Policlinico Universitario “Vittorio Emanuele” Presidio Ospedaliero Ferrarotto – Divisione Clinicizzata di Ematologia – Prof. Francesco  Di Raimondo diraimon@unict.it
  • Cosenza  Azienda Ospedaliera di Cosenza – Divisione Onco Ematologia – Dr. Ernesto Vigna
  • Messina  A. O. Papardo di Messina – Divisione di Ematologia – Dr. Donato Mannina
  • Milano Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico – Dipartimento di Ematologia – Prof. Agostino Cortelezzi  agostino.cortelezzi@unimi.it
  • Pescara Ospedale Civile Spirito Santo – Divisione di Ematologia – Dr. Paolo Di Bartolomeo paolo.dibartolomeo@ausl.pe.it
  • Reggio Calabria (coordinating center) Grande Ospedale Metropolitano “B. M. M.” –  Dipartimento di Ematologia –  Dr. Esther Natalie Oliva   enoliva@gmail.com
  • Rionero in Vulture (PZ)  Centro di Riferimento Oncologico di Basilicata – Dipartimento Onco-Ematologico – Dr. Pellegrino Musto
  • Roma  Ospedale Sant’Eugenio –  U. O. C. Ematologia – Dr. Pasquale Niscola
  • Roma  IRCCS Istituto Regina Elena (IFO) –  Divisione di Ematologia – Dr. Atelda Romano
  • San Giovanni Rotondo (FG) Ospedale Casa Sollievo della Sofferenza – Ematologia e Centro Trapianti – Dr. Nicola Cascavilla n.cascavilla@operapadrepio.it
  • Udine A. O. U. Integrata di Udine – Clinica Ematologica – Prof. Anna Candoni  anna.candoni@asuiud.sanita.fvg.it

EQol MDS  “Eltrombopag for the treatment of thrombocytopenia due to low- and intermediate risk myelodysplastic syndromes.”

Eudract number 2010-022890-33

https://www.clinicaltrialsregister.eu/ctr-search/search?query=EQOL-MDS

International multicenter, single-blind, randomized, placebo-controlled, study.

In patients myelodysplastic syndrome (MDS) with thrombocytopenia and low- or intermediate-1 IPSS risk with severe piastrinopenia there is an increased hemorrhagic risk.

In Europe The only available treatment for severe thrombocytopenia, in the presence of bleeding, is platelet (PLT) transfusions., and in few cases the allogeneic bone marrow transplantation, while in the USA it is possible to offer azacitidine treatment.

Objectives  of the study are to assess the platelet response rate in the proportion of patients in the experimental arm with eltrombopag versus the patients in the placebo controlled arm.  In addition will be assessed the safety and tolerability in terms of frequency and severity of adverse events, quality of life and overall survival in the two groups.

To see the preliminary result of the study, please see the following article:

Eltrombopag versus placebo for low-risk myelodysplastic syndromes with thrombocytopenia (EQoL-MDS): phase 1 results of a single-blind, randomised, controlled, phase 2 superiority trial. Lancet Haematol. 2017 Mar;4(3):e127-e136. doi: 10.1016/S2352-3026(17)30012-1. Epub 2017 Feb 3.

https://www.ncbi.nlm.nih.gov/pubmed/28162984

Participating centers:

Italy:

  • Alessandria Azienda Ospedaliera Nazionale  SS. Antonio e Biagio e Cesare Arrigo, Division of Hematology. Dr. Flavia Salvi  flaviasalvi@hotmail.com

https://www.ospedale.al.it/sc-ematologia/

 

http://www.ospedaliriuniti.marche.it/portale/archivio13_clinicaematologica-ancona_0_302_1.html

 

  • Asti  Ospedale Cardinal Massaia di Asti,  Oncology Unit. Dr. Monia Marchetti  MMarchetti@asl.at.it

http://portale.asl.at.it/Apps/portaleasl.nsf/tmp_contenuti.htm?OpenPage&var1=repo_oncologia

 

  • Bari Azienda Ospedaliera Universitaria Policlinico, Hematology and Hemopoietic Stem Cells Transplantation Unit. Prof. Giorgina Specchia  giorgina.specchia@uniba.it

https://www.sanita.puglia.it/web/ospedalegiovannixxiii/unita-operative_det/-/journal_content/56/36067/ematologia-con-trapianto-universitaria

 

https://www.sanita.puglia.it/web/irccs/trova-un-medico_det/-/journal_content/56/36096/ematolog-1

 

  • BeneventoAzienda Ospedaliera San Pio ( Ex A. O. “G. Rummo”), Hematology  DH and Transfusion Unit . Dr. Roberto Vallonevallone@ao-rummo.it

http://aosanpio.it/

 

  • Biella Ospedale degli Infermi, Hematology Division Dr. Andrea Castelli andrea.castelli@aslbi.piemonte.it

https://aslbi.piemonte.it/reparti-e-servizi/ospedale/ematologia/

 

https://www.ematologiabrindisi.it/it/

https://www.aslcagliari.it/index.php?xsl=7&s=9341&v=2&c=615

 

  • Catania Policlinico Universitario “Vittorio Emanuele” Presidio Ospedaliero Ferrarotto , Hematology Division. Prof. Francesco  Di Raimondo diraimon@unict.it

https://www.policlinicovittorioemanuele.it/po-ferrarotto-alessi-ematologia-e-trapianto-di-midollo-osseo-attivita-di-ricerca-didattica-e-scientifica

 

  • Chivasso (TO)ASL TO4 Azienda Sanitaria Locale di Ciriè, Chivasso, Ivrea, Hematology Division. Emanuela Messa emanuelamessa@yahoo.it

https://www.aslto4.piemonte.it/menu.asp?a=2

 

  • Cosenza  Azienda Ospedaliera di Cosenza , Onco- Hematology Division.  Dr. Ernesto Vigna ernesto.vigna@aocs.it

https://www.aocosenza.it/dipartimenti-sanitari/dipartimento-oncoematologico/unita-operative-complesse/ematologia/

 

  • Cremona A. S.S. T.,  Hematology Division. Dr. Alfredo Molteni  alfredo.molteni@asst-cremona.it

http://www.ospedale.cremona.it/public/htm/UOcremona-oncologia-ematologia-istituti-ospitalieri-cremona.php

 

  • Firenze Azienda Ospedaliera Universitaria Careggi, Functional Unit of Haematology.  Prof. Valeria Santini valeria.santini@unifi.it

https://www.aou-careggi.toscana.it/internet/index.php?option=com_content&view=article&id=641&catid=122&Itemid=909&lang=it

 

  • Frosinone Ospedale “Fabrizio Spaziani” di Frosinone, O. C. Hematology . Dr. Alessandro Andriani  alessandro.andriani1@tin.it

https://www.asl.fr.it/strutture/presidi-ospedalieri/presidio-ospedaliero-frosinone-alatri/uoc-ematologia

 

  • Genova Ospedale San Martino,  Internal Medicine Department. Dr. Enrico Balleari balleari@unige.it

http://www.ospedalesanmartino.it/

https://www.sanita.puglia.it/web/asl-lecce/ospedali_det/-/journal_content/56/25176/ematolog-1

 

http://www.aopapardo.it/?page_id=681

 

  • Messina  A. O. U. Policlinico G. Martino, Hematology Division. Prof. Caterina Musolino cmusolino@unime.it

https://www.polime.it/azienda/scheda_uoc?p_uoc=506600

 

  • Milano Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Hematology Department. Dr. Gianluigi Reda  gianluigi.reda@policlinico.mi.it

https://www.policlinico.mi.it/reparti/21/ematologia

 

https://www.ospedaleniguarda.it/strutture/info/ematologia

 

  • NapoliO.U. Federico II di Napoli, Hematology Department. Prof. Fabrizio Pane fabrizio.pane@unina.it

http://www.policlinico.unina.it/flex/cm/pages/ServeBLOB.php/L/IT/IDPagina/1

 

  • Novara Azienda Ospedaliero-Universitaria Maggiore della Carità, Hematology. Dr. Elena Crisà crisa@uniupo.it

 

http://www.maggioreosp.novara.it/site/home/attivita-assistenziale/strutture-sanitarie/elenco-delle-strutture-sanitarie/scheda8000138.html

 

http://www.aslsalerno.it/presidio-ospedaliero-andrea-tortora-di-pagani

 

https://www.ausl.pe.it/DettaglioUUUA.jsp?id=27

 

  • Reggio Calabria (centro coordinatore) Grande Ospedale Metropolitano “B. M. M.” , Hematology Division. Dr. Esther Natalie Oliva   enoliva@gmail.com

http://www.ospedalerc.it/reparto/ematologia/

 

http://www.asmn.re.it/informazioni-di-accesso-ai-servizi-clinici/ematologia

  • Roma Policlinico Umberto I- Università “La Sapienza”, Department of Cellular Biotechnology and Haematology. Dr.Roberto Latagliata latagliata@bce.uniroma1.it

http://www.ematologialasapienza.it/

  • Roma Policlinico Universitario Tor Vergata, Department of Biopathology and Imaging Diagnostics.   Dr. Francesco Buccisano francesco.buccisano@uniroma2.it

http://www.ptvonline.it/uo_pato_mielo.asp

 

  • Roma  Ospedale Sant’ Eugenio,  Hematology Unit. Dr. Pasquale Niscola pniscola@gmail.com

http://www.aslroma2.it/index.php/area-medica-per-intensita-di-cure-ose/uoc-ematologia-ose

  • Roma Università Campus Biomedico,  Hematology, stem cell transplantation, transfusion medicine and cell therapy Unit. Prof. Giuseppe Avvisati g.avvisati@unicampus.it 

https://www.policlinicocampusbiomedico.it/unita-operativa/ematologia-e-trapianto-di-cellule-staminali

 

http://www.policlinicogemelli.it/Struttura.aspx?UOC=3DE3C0D6-EAF4-442F-AE52-CE5FBBEED3A0

 

http://www.scamilloforlanini.rm.it/sperimentazioni-ematologia

 

http://www.ifo.it/index/attivita-cliniche/area-medicina-oncologica/ematologia.html

 

https://www.aslroma1.it/azienda-dipartimentieri/dipartimento-oncologico

  • Salerno  A .O. U. San Giovanni di Dio e Ruggì D’Aragona, Hematology and Stem cells Transplantation Unit. Prof. Carmine Selleri  cselleri@unisa.it 

http://www.sangiovannieruggi.it/index.php/attivita-sanitarie/ematologia-e-trapianti-di-cellule-staminali

 

  • San Giovanni Rotondo (FG) Ospedale Casa Sollievo della Sofferenza, Hematology and Transplantation Unit. Dr. Nicola Cascavilla n.cascavilla@operapadrepio.it

https://www.operapadrepio.it/it/ematologia.html

 

  • Siena A. O. U. Senese Policlinico Santa Maria alle Scotte, Hematology Unit. Dr. Monica Bocchia bocchia@unisi.it 

http://www.ao-siena.toscana.it/index.php/dipartimento-oncologico/ematologia

 

  • Terni  Azienda Ospedaliera Santa Maria, Onco-Hematology Division. Prof. Anna Marina Liberati  marina.liberati@unipg.it

http://www.aospterni.it/pagine/dipartimento-di-oncologia

 

  • Torino A. O. Città della Salute e della Scienza di Torino, Department of Molecular Biotechnology and Health Sciences – Hematology  University of Turin. Prof. Dario Ferrero dario.ferrero@unito.it

https://www.cittadellasalute.to.it/index.php?option=com_content&view=article&id=216:ematologia-u&catid=140&Itemid=412

 

  • Udine Azienda Sanitaria Universitaria Integrata di Udine- Presidio Ospedaliero Santa Maria della Misericordia, Hematology Prof. Anna Candoni  anna.candoni@asuiud.sanita.fvg.it

https://asuiud.sanita.fvg.it/distretti/dipartimenti-ospedalieri/ospedale-smm/medicina-specialistica/clinica-ematologica

 

https://www.aulss8.veneto.it/nodo.php/79

 

http://www.asl.vt.it/Oncologia/Ematologia/base.php

 

Germania

  • Düsseldorf ( centro coordinator per la Germania)  Heinrich-Heine University – Department of Haematology, Oncology and Clinical Immunology – Prof. Ulrich Germing  Germing@med.uni-duesseldorf.de

https://www.uniklinik-duesseldorf.de/en/department-of-haematology-oncology-and-clinical-immunology

 

  • Mannehim University Hospital of Mannheim –  Department of Hematology and Oncology – Prof. Georgia Metzgeroth georgia.metzgeroth@umm.de

https://w2.umm.de/umm/medical-departments/

QOL-ONE Trans-1 “Accuracy of alternative TP53 somatic mutational and expression analyses for the prognostication of myelodysplastic syndrome”

National, multicenter, non-interventional, prospective, observational trial.

The prognosis of patients with isolated del5q MDS is and partly dependent on the mutation of the TP53 gene in the neoplastic clone. An accurate laboratory methodology for the prognosis of these patients is useful for the choice of the treatment, especially in patients with MDS with severe prognosis del5q.

The primary objective of the study is to evaluate the concordance between TP53 expression in IHC and in qPCR realtime relative method on BM blood sample, in terms of proportion of patients with concordance. Will be also evaluate the frequency of TP53 somatic mutations in the MDS sample by SNP single assay; the prognostic value on disease progression of the mutational status on BM blood sample compared to the expression in IHC and in qPCR realtime relative method on BM blood sample; the prognostic value on overall survival of the mutational status on BM blood sample compared to the expression in IHC and in qPCR realtime relative method on BM blood sample

Participating centers:

Italy:

  • Alessandria  Azienda Ospedaliera Nazionale  SS. Antonio e Biagio e Cesare Arrigo, Division of Hematology. Dr. Flavia Salvi flaviasalvi@hotmail.com

https://www.ospedale.al.it/sc-ematologia/

 

http://www.ospedaliriuniti.marche.it/portale/archivio13_clinicaematologica-ancona_0_302_1.html

 

  • Asti  Ospedale Cardinal Massaia di Asti,  Oncology Unit. Dr. Monia Marchetti  MMarchetti@asl.at.it

http://portale.asl.at.it/Apps/portaleasl.nsf/tmp_contenuti.htm?OpenPage&var1=repo_oncologia

 

  • Bari Azienda Ospedaliera Universitaria Policlinico, Hematology and Hemopoietic Stem Cells Transplantation Unit. Dr. Francesco Albano   francesco.albano@uniba.it

https://www.sanita.puglia.it/web/ospedalegiovannixxiii/unita-operative_det/-/journal_content/56/36067/ematologia-con-trapianto-universitaria

https://www.aslcagliari.it/index.php?xsl=7&s=9341&v=2&c=615

 

  • Catania Policlinico Universitario “Vittorio Emanuele” Presidio Ospedaliero Ferrarotto , Hematology Division. Prof. Francesco  Di Raimondo diraimon@unict.it

https://www.policlinicovittorioemanuele.it/po-ferrarotto-alessi-ematologia-e-trapianto-di-midollo-osseo-attivita-di-ricerca-didattica-e-scientifica

  • Cosenza  Azienda Ospedaliera di Cosenza , Onco- Hematology Division.  Dr. Ernesto Vigna ernesto.vigna@aocs.it

https://www.aocosenza.it/dipartimenti-sanitari/dipartimento-oncoematologico/unita-operative-complesse/ematologia/

 

  • Cremona A. S.S. T., Hematology Division. Dr. Alfredo Molteni  alfredo.molteni@asst-cremona.it

http://www.ospedale.cremona.it/public/htm/UOcremona-oncologia-ematologia-istituti-ospitalieri-cremona.php

 

https://www.sanita.puglia.it/web/asl-lecce/ospedali_det/-/journal_content/56/25176/ematolog-1

 

http://www.aopapardo.it/?page_id=681

 

  • Milano Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Hematology Department. Dr. Gianluigi Reda  gianluigi.reda@policlinico.mi.it

https://www.policlinico.mi.it/reparti/21/ematologia

 

https://www.ospedaleniguarda.it/strutture/info/ematologia

 

  • Napoli A.O.U. Federico II di Napoli, Hematology Department. Prof. Fabrizio Pane  fabrizio.pane@unina.it

http://www.policlinico.unina.it/flex/cm/pages/ServeBLOB.php/L/IT/IDPagina/1

 

https://www.ausl.pe.it/DettaglioUUUA.jsp?id=27

 

  • Reggio Calabria (centro coordinatore) Grande Ospedale Metropolitano “B. M. M.” , Hematology Division.  Dr. Esther Natalie Oliva   enoliva@gmail.com

http://www.ospedalerc.it/reparto/ematologia/

 

http://www.asmn.re.it/informazioni-di-accesso-ai-servizi-clinici/ematologia

  • Roma Policlinico Universitario Tor Vergata, Department of Biopathology and Imaging Diagnostics.   Dr. Francesco Buccisano  francesco.buccisano@uniroma2.it

http://www.ptvonline.it/uo_pato_mielo.asp

 

  • Roma  Ospedale Sant’ Eugenio, Hematology Unit. Dr. Pasquale Niscola  pniscola@gmail.com

http://www.aslroma2.it/index.php/area-medica-per-intensita-di-cure-ose/uoc-ematologia-ose

http://www.hsangiovanni.roma.it/13-reparti-1.html

  

http://www.policlinicogemelli.it/Struttura.aspx?UOC=3DE3C0D6-EAF4-442F-AE52-CE5FBBEED3A0

 

http://www.ifo.it/index/attivita-cliniche/area-medicina-oncologica/ematologia.html

 

  • Salerno  A .O. U. San Giovanni di Dio e Ruggì D’Aragona, Hematology and Stem cells Transplantation Unit. Prof. Carmine Selleri  cselleri@unisa.it 

http://www.sangiovannieruggi.it/index.php/attivita-sanitarie/ematologia-e-trapianti-di-cellule-staminali

  • San Giovanni Rotondo (FG) Ospedale Casa Sollievo della Sofferenza, , Hematology and Transplantation Unit. Dr. Nicola Cascavilla  n.cascavilla@operapadrepio.it

https://www.operapadrepio.it/it/ematologia.html

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