LEONIDAS: Quality of Life Study in Chronic Myeloid Leukemia Patients

NCT ID: NCT02164903

Last Updated: 2018-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 323 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-11
• Study Completion Date: 2018-10-31

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.

Detailed Description

The development of molecular targeted therapies (i.e., oral tyrosine kinase inhibitors [TKIs]) to treat chronic myeloid leukemia (CML) is one of the great triumphs of modern oncology and one of the spearheads of personalized medicine. Since their introduction in 2001, the number of people living with CML has doubled, a trend that is expected to continue.

This study (i.e., LEONIDAS) is set up to generate evidence-based data and produce information that will advance scientific knowledge, clinical practice and health services management to facilitate clinical decision-making in CML.

In an effort to further promote patient-centered care for CML a patient advocacy organization, that is the: CML Advocates Network, is involved in this project with key representatives who will be in the advisory board team. The CML Advocates Network, hosted by the patient-run, non-profit Leukemia Patient Advocates Foundation is a worldwide network of 82 non-profit organizations from 63 countries supporting patients with CML and their relatives.

Rationale and Significance Some ten years ago, the treatment of CML was relatively straightforward as all patients received imatinib as first-line treatment and for those who failed imatinib, the only available proven alternative was allogeneic stem cell transplantation. Nowadays, with three effective drugs (i.e., imatinib, nilotinib and dasatinib), that can be used frontline in newly diagnosed chronic phase (CP) CML patients, treatment decision-making for individual patients in daily clinical practice has thus rapidly grown in complexity. Moreover, a new tyrosine kinase inhibitors (TKI), bosutinib, has been recently approved for as second-line treatment and undergoing clinical trials are assessing its efficacy as frontline strategy in CML.

To further complicate the scenario, is the fact that despite nilotinib and dasatinib have been shown to have higher rates of cytogenetic and molecular responses (compared to imatinib), none of these three drugs is dramatically better than the others. To illustrate, only slightly differences exist in terms of progression-free survival for nilotinib and no differences for overall survival at 24 and/or 36 months amongst imatinib, dasatinib and nilotinib.

Nevertheless, physician-reported toxicity data suggests these drugs have different toxicity profiles, with imatinib inducing a higher proportion of low-grade side effects than second generation tyrosine kinase inhibitors (TKI) (i.e. nilotinib and dasatinib).

While a wealth of biomedical and laboratory data exists on clinical efficacy of these three drugs, the impact of these from the patients' perspective, in terms of Quality of Life (QoL) and symptom burden, has been poorly investigated. No data exists on QoL of patients treated with nilotinib or dasatinib and it is not known if these drugs provide better QoL outcomes over imatinib when used as first line therapy. Such information would be critical in the current CML arena to make more informed treatment decisions. This is a significant gap in our knowledge with respect to the modern management of CML, also because, as long-term continuous exposure to the tyrosine kinase inhibitors (TKI) is necessary, even low grade side effects can heavily impact on patients' QoL.

Thus, the objective 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, as well as characterizing medication-taking behavior associated with imatinib or dasatinib.

Conditions

Chronic Myeloid Leukemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Imatinib

Patients in first line treatment with imatinib for no more than 3 years.

QoL Survey Booklet

Intervention Type: OTHER

Dasatinib

Patients in first line treatment with dasatinib for no more than 3 years.

QoL Survey Booklet

Intervention Type: OTHER

Interventions

QoL Survey Booklet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Leukemia Net

UNKNOWN

Sponsor Role: collaborator

CML Advocates Network

UNKNOWN

Sponsor Role: collaborator

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabio Efficace, PhD

Role: STUDY_CHAIR

Gruppo Italiano Malattie EMatologiche dell'Adulto

Gianantonio Rosti, Dr.

Role: STUDY_DIRECTOR

University of Bologna

Locations

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

Countries

France; Germany; Italy; Spain

Related Links

http://www.gimema.it

Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Foundation

Other Identifiers

QoL-CML0713

Identifier Type: -

Identifier Source: org_study_id