LEONIDAS: Quality of Life Study in Chronic Myeloid Leukemia Patients
QoL-CML0713
Mid to Long-term Quality of Life Effects Of imatiNIb Versus DASatinib in Chronic Myeloid Leukemia Patients (LEONIDAS)
1 other identifier
observational
323
4 countries
49
Brief Summary
The broad goal of this study is to investigate if differences exist (and in which areas and of what magnitude) in QoL and symptoms of patients with CML being treated with first line therapy with dasatinib versus those receiving first line therapy with imatinib. Also, an additional objective is to characterize medication-taking behavior associated with imatinib or dasatinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Longer than P75 for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2014
CompletedFirst Posted
Study publicly available on registry
June 17, 2014
CompletedStudy Start
First participant enrolled
September 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedAugust 6, 2018
August 1, 2018
2.4 years
May 27, 2014
August 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of the impact of therapy on daily life in patients with CP-CML being treated with first line therapy with dasatinib and those receiving first line therapy with imatinib.
(outcome measure: European Organization for Research and EORTC QLQ-CML24 "Impact on daily life" scale)
24 months.
Secondary Outcomes (4)
Differences in Patient-reported outcomes between imatinib- and dasatinib- treated CP- CML patients in the following QoL domains: Fatigue, Physical, Social and Role Functioning and Impact on worry and mood and Symptom burden.
24 months.
Proportion of patients considered as low, medium and high adheres by type of therapy.
24 months.
Relationship between patient's perception of disease-/treatment-related information received , QoL profile and adherence to therapy.
24 months.
Degree of agreement in the assessment of symptom severity, for a set of core CML treatment related symptoms , between patients and their treating physicians.
24 months.
Study Arms (2)
Imatinib
Patients in first line treatment with imatinib for no more than 3 years.
Dasatinib
Patients in first line treatment with dasatinib for no more than 3 years.
Interventions
Eligibility Criteria
Adult chronic myeloid leukemia patients in first line treatment with either dasatinib or imatinib for no more than 3 years.
You may qualify if:
- years or older at the time of study entry;
- Diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive CML confirmed by cytogenetic and/or molecular analysis;
- At least in CCyR (as documented by chromosome banding analysis of marrow cell metaphases) or in MMR (≤0.1% BCR-ABL IS)
- CP-CML Patients in first line treatment with either dasatinib or imatinib for no more than 3 years;
- Written informed consent.
You may not qualify if:
- Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
- Not speaking and reading the language of the participating country.
- Having received any CML treatment prior to therapy with imatinib or dasatinib for more than three months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gruppo Italiano Malattie EMatologiche dell'Adultolead
- European Leukemia Netcollaborator
- CML Advocates Networkcollaborator
Study Sites (49)
Department of Hematology and Oncology, Hôpital Mignot, Université Versailles Saint-Quentin-en-Yvelines
Le Chesnay, France
Universität Heidelberg - III. Medizinische Klinik - Universitätsmedizin Mannheim
Mannheim, Germany
Universitat Heidelberg
Mannhein, Germany
S. C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Clinica di Ematologia - Azienda Ospedaliera Regionale di Torrette
Ancona, Italy
U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari
Bari, Italy
Istituto di Ematologia "L. e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, Italy
USD - Centro Trapianti Midollo Osseo Adulti - Cattedra di Ematologia - Azienda Spedali Civili - Brescia
Brescia, Italy
U.O. Ematologia Brindisi- Ospedale A. Perrino ASL BR
Brindisi, Italy
CTMO-Ematologia-Ospedale "Binaghi"
Cagliari, Italy
U.O. Ematologia CTMO "Businco"
Cagliary, Italy
Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto
Catania, Italy
Azienda Ospedaliera - Arcispedale S. Anna Sezione di Ematologia e Fisiopatologia delle Emostasi
Ferrara, Italy
Divisione di Ematologia - Policlinico Careggi
Florence, Italy
Clinica Ematologica - Dipartimento di Medicina Interna - IRCCS San Martino - IST
Genova, Italy
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina, Italy
Divisione Ematologia - Dipartimento di Medicina Interna -Policlinico Universitario di Messina
Messina, Italy
U.O. Ematologia - Azienda USLL12 Veneziana - Ospedale dell'Angelo e Ospedale civile S. Giovanni e Paolo
Mestre - Venezia, Italy
U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano
Milan, Italy
Dipartimento di Med. Clinica e Sperimentale- Area di Ematologia - Facoltà di Medicina e Chirurgia - Università degli Studi di Napoli "Federico II" -
Napoli, Italy
U.O. Ematologia - Ospedale S. Gennaro
Napoli, Italy
XIX Divisione di Ematologia con trapianto - A.O.R.N. "A. Cardarelli"
Napoli, Italy
Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato"
Novara, Italy
Dipartimento di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga
Orbassano, Italy
Ematologia ed Immunologia Clinica - Università degli studi di Padova
Padua, Italy
Divisione di Ematologia con trapianto di midollo - A.O.U. Policlinico "Paolo Giaccone"
Palermo, Italy
U.O.C. Ematologia - A.O. Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, Italy
Ematologia e CTMO - A.O.U. Università degli Studi di Parma
Parma, Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
Piacenza, Italy
U.O. Ematologia - A.O.U. Pisana
Pisa, Italy
U.O. Ematologia - A.O. San Carlo
Potenza, Italy
Divisione di Ematologia - A.O. Ospedali Riuniti di Reggio Calabria "Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
Rimini Ospedale "Infermi"
Rimini, Italy
Department of Onco-Hematology - IRCCS; Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture, Italy
Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza"
Roma, Italy
Divisione di Ematologia - Ospedale S.Eugenio
Roma, Italy
Ematologia - A.O. Sant'Andrea
Roma, Italy
Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)
Roma, Italy
U.O. di Ematologia - Ente Ospedaliero San Giovanni Addolorata
Roma, Italy
U.O.C. Ematologia e Trapianto cellule staminali - Pad Cesalpino- A.O. San Camillo Forlanini
Roma, Italy
U.O. di Ematologia - Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Ematologia - AOU Sassari
Sassari, Italy
U.O.C. Ematologia - A.O. SS Annunziata - P.O.S.G. Moscati
Taranto, Italy
S.C. di Oncoematologia - A.O. "S. Maria"
Terni, Italy
S.C.D.O. Ematologia II - A.O.U.S. San Giovanni Battista di Torino (Molinette)
Torino, Italy
Clinica Ematologica ed Unità di Terapie Cellulari Carlo Melzi - A.O. Universitaria
Udine, Italy
Onco-Ematologia - Ospedale S. Andrea- Vercelli
Vercelli, Italy
U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Department of Hematology, Hospital Universitario de la Princesa
Madrid, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fabio Efficace, PhD
Gruppo Italiano Malattie EMatologiche dell'Adulto
- STUDY DIRECTOR
Gianantonio Rosti, Dr.
University of Bologna
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2014
First Posted
June 17, 2014
Study Start
September 11, 2014
Primary Completion
January 25, 2017
Study Completion
October 1, 2018
Last Updated
August 6, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share