LEONIDAS: Quality of Life Study in Chronic Myeloid Leukemia Patients

Chronic Myeloid Leukemia Clinical Trial

— QoL-CML0713  

Official title:

Mid to Long-term Quality of Life Effects Of imatiNIb Versus DASatinib in Chronic Myeloid Leukemia Patients (LEONIDAS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02164903
• Other study ID #: QoL-CML0713
• Status: Active, not recruiting
• Start date: September 11, 2014
• Est. completion date: October 2018

Study information

• Verified date: August 2018
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 323
• Est. completion date: October 2018
• Est. primary completion date: January 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Other:
• QoL Survey Booklet

Locations

Country	Name	City	State
France	Department of Hematology and Oncology, Hôpital Mignot, Université Versailles Saint-Quentin-en-Yvelines	Le Chesnay
Germany	Universität Heidelberg - III. Medizinische Klinik - Universitätsmedizin Mannheim	Mannheim
Germany	Universitat Heidelberg	Mannhein
Italy	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	Firenze
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	Milano
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	Padova
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
Spain	Department of Hematology, Hospital Universitario de la Princesa	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto	CML Advocates Network, European Leukemia Net

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	(outcome measure: EORTC QLQ-C30 and EORTC QLQ-CML24)	24 months.
Secondary	Proportion of patients considered as low, medium and high adheres by type of therapy.	(outcome measure: Morisky-Medication Adherence Scale-MMAS)	24 months.
Secondary	Relationship between patient's perception of disease-/treatment-related information received , QoL profile and adherence to therapy.	(defined according to the EORTC-QLQ-INFO25)	24 months.
Secondary	Degree of agreement in the assessment of symptom severity, for a set of core CML treatment related symptoms , between patients and their treating physicians.	(according to the EORTC-QLQ-CML24)	24 months.

External Links

•   Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Foundation