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.
ONGOING CLINICAL TRIALS
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:
Italy
- Alessandria Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo, Division of Hematology. Dr. Flavia Salvi flaviasalvi@hotmail.com
- Ancona Ospedali Riuniti di Ancona, SOD Hematology Clinic. Prof. Antonella Poloni antonella.poloni@ospedaliriunitimarche.marche.it
- Avellino San Giovanni Moscati Hospital, Hematology Division. Dr. Antonio Volpe volpe66@cheapnet.it
- Bari Azienda Ospedaliera Universitaria Policlinico, Hematology and Hemopoietic Stem Cells Transplantation Unit. Prof. Giorgina Specchia giorgina.specchia@uniba.it
- Catania Policlinico Universitario “Vittorio Emanuele” Presidio Ospedaliero Ferrarotto, Hematology Division. Prof. Francesco Di Raimondo diraimon@unict.it
- Cosenza Azienda Ospedaliera di Cosenza, Onco-Hematology Division. Dr. Ernesto Vigna ernesto.vigna@aocs.it
- Messina A. O. Papardo di Messina, Hematology Division. Dr. Donato Mannina
- donatomannina@aziendaospedalierapapardo.it
- Milan Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Hematology Department. Dr. Gianluigi Reda gianluigi.reda@policlinico.mi.it
- Pescara Ospedale Civile Spirito Santo, Hematology Division. Dr. Prassede Salutari prassede.salutari@ausl.pe.it
- Reggio Calabria (coordinating center) Grande Ospedale Metropolitano “B. M. M.”, Hematology Division. Dr. Esther Natalie Oliva enoliva@gmail.com
- Rionero in Vulture (PZ) IRCCS CROB, Onco-Hematology Department. Dr. Pellegrino Musto p.musto@tin.it
- Rome Ospedale Sant’ Eugenio, Hematology Unit. Dr. Pasquale Niscola pniscola@gmail.com
- Rome IRCCS Istituto Regina Elena (IFO), Hematology Division. Dr. Atelda Romano atelda.romano@ifo.gov.it
- San Giovanni Rotondo (FG) Ospedale Casa Sollievo della Sofferenza, Hematology and Transplantation Unit. Dr. Nicola Cascavilla n.cascavilla@operapadrepio.it
- Udine Azienda Sanitaria Universitaria Integrata di Udine-Presidio Ospedaliero Santa Maria della Misericordia, Hematology Clinic. 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
- Ancona Ospedali Riuniti di Ancona, SOD Hematology Clinic. Prof. Antonella Poloni antonella.Poloni@ospedaliriuniti.marche.it
- Asti Ospedale Cardinal Massaia di Asti, Oncology Unit. Dr. Monia Marchetti MMarchetti@asl.at.it
- Bari Azienda Ospedaliera Universitaria Policlinico, Hematology and Hemopoietic Stem Cells Transplantation Unit. Prof. Giorgina Specchia giorgina.specchia@uniba.it
- Bari Istituto Tumori di Bari “Giovanni Paolo II”, Hematology Division. Dr. Attilio Guarini attilioguarini@oncologico.bari.it
- Benevento Azienda Ospedaliera San Pio (Ex A. O. “G. Rummo”), Hematology DH and Transfusion Unit. Dr. Roberto Vallone vallone@ao-rummo.it
- Biella Ospedale degli Infermi, Hematology Division. Dr. Andrea Castelli andrea.castelli@aslbi.piemonte.it
- Brindisi Ospedale “Antonio Perrino”, Hematology U. O. C. Dr. Domenico Pastore domenico.pastore0@gmail.com
- Cagliari Ospedale Roberto Binaghi, Hematology Unit. Dr. Giovanni Caocci giovanni.caocci@unica.it
- Catania Policlinico Universitario “Vittorio Emanuele” Presidio Ospedaliero Ferrarotto, Hematology Division. Prof. Francesco Di Raimondo diraimon@unict.it
- Chivasso (TO) ASL TO4 Azienda Sanitaria Locale di Ciriè, Chivasso, Ivrea, Hematology Division. Emanuela Messa emanuelamessa@yahoo.it
- Cosenza Azienda Ospedaliera di Cosenza, Onco-Hematology Division. Dr. Ernesto Vigna ernesto.vigna@aocs.it
- Cremona A. S.S. T., Hematology Division. Dr. Alfredo Molteni alfredo.molteni@asst-cremona.it
- Florence Azienda Ospedaliera Universitaria Careggi, Functional Unit of Hematology. Prof. Valeria Santini valeria.santini@unifi.it
- Frosinone Ospedale “Fabrizio Spaziani” di Frosinone, O. C. Hematology. Dr. Alessandro Andriani alessandro.andriani1@tin.it
- Genoa Ospedale San Martino, Internal Medicine Department. Dr. Enrico Balleari balleari@unige.it
- Lecce Ospedale Vito Fazzi, Hematology Unit. Dr. Nicola Di Renzo direnzo.ematolecce@gmail.com
- Messina A. O. Papardo di Messina, Hematology Division. Dr. Donato Mannina donatomannina@aziendaospedalierapapardo.it
- Messina A. O. U. Policlinico G. Martino, Hematology Division. Prof. Caterina Musolino cmusolino@unime.it
- Milan Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Hematology Department. Dr. Gianluigi Reda gianluigi.reda@policlinico.mi.it
- Milan Ospedale Niguarda, Hematology Division. Dr. Marta Riva marta.riva@ospedaleniguarda.it
- Naples A.O.U. Federico II di Napoli, Hematology Department. Prof. Fabrizio Pane fabrizio.pane@unina.it
- Novara Azienda Ospedaliero-Universitaria Maggiore della Carità, Hematology Division. Dr. Elena Crisà crisa@uniupo.it
- Pagani (SA) A.O. “A. Tortora” Pagani – AsL Salerno, Hematology Unit. Dr. Flavia Rivellini f.rivellini@aslsalerno.it
- Pescara Ospedale Civile Spirito Santo, Hematology Division. Dr. Prassede Salutari prassede.salutari@ausl.pe.it
- Reggio Calabria (coordinating center) Grande Ospedale Metropolitano “B. M. M.”, Hematology Division. Dr. Esther Natalie Oliva enoliva@gmail.com
- Reggio Emilia Arcispedale Santa Maria Nuova, Hematology Unit. Dr. Isabella Capodanno isabella.capodanno@asmn.re.it
- Rome Policlinico Umberto I- Università “La Sapienza”, Department of Cellular Biotechnology and Haematology. Dr.Roberto Latagliata latagliata@bce.uniroma1.it
- Rome Policlinico Universitario Tor Vergata, Department of Biopathology and Imaging Diagnostics. Dr. Francesco Buccisano francesco.buccisano@uniroma2.it
- Rome Ospedale Sant’ Eugenio, Hematology Unit. Dr. Pasquale Niscola pniscola@gmail.com
- Rome Università Campus Biomedico, Hematology, stem cell transplantation, transfusion medicine and cell therapy Unit. Prof. Giuseppe Avvisati g.avvisati@unicampus.it
- Rome Policlinico Gemelli, Hematology Unit. Dr. Luana Fianchi luana.fianchi@policlinicogemelli.it
- Rome Ospedale San Camillo Forlanini, Hematology and Transplantation Division. Dr. Stefano Mancini smancini@scamilloforlanini.rm.it
- Rome IRCCS Istituto Regina Elena (IFO), Hematology Division. Dr. Atelda Romano atelda.romano@ifo.gov.it
- Rome Ospedale Nuovo Regina Margherita, Hematology Division. Dr. Alessandro Andriani alessandro.andriani1@tin.it
- Salerno A .O. U. San Giovanni di Dio e Ruggì D’Aragona, Hematology and Stem cells Transplantation Unit. Prof. Carmine Selleri cselleri@unisa.it
- San Giovanni Rotondo (FG) Ospedale Casa Sollievo della Sofferenza, Hematology and Transplantation Unit. Dr. Nicola Cascavilla n.cascavilla@operapadrepio.it
- Siena A. O. U. Senese Policlinico Santa Maria alle Scotte, Hematology Unit. Dr. Monica Bocchia bocchia@unisi.it
- Terni Azienda Ospedaliera Santa Maria, Onco-Hematology Division. Prof. Anna Marina Liberati marina.liberati@unipg.it
- Turin 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
- Udine Azienda Sanitaria Universitaria Integrata di Udine- Presidio Ospedaliero Santa Maria della Misericordia, Hematology Clinic. Prof. Anna Candoni anna.candoni@asuiud.sanita.fvg.it
- Vicenza Ospedale San Bortolo, Hematology Unit. Dr. Marco Ruggeri ruggeri@hemato.ven.it
- Viterbo Ospedale Belcolle, Hematology Unit. Dr. Giulio Trapè giuliotrape@libero.it
Germany
- Düsseldorf (coordinating center) Heinrich-Heine University, Department of Haematology, Oncology and Clinical Immunology. Prof. Ulrich Germing Germing@med.uni-duesseldorf.de
- Mannehim University Hospital of Mannheim, Department of Hematology and Oncology. Prof. Georgia Metzgeroth georgia.metzgeroth@umm.de