Chronic Myeloid LeukemiaQoL-CML0713NCT02164903
LEONIDAS: Quality of Life Study in Chronic Myeloid Leukemia Patients
An observational study of Chronic Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 49 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- QoL Survey Booklet
- How many people
- 323 participants
- Where
- 49 sitesin 4 countries
- Study dates
- 11 Sep 2014to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult chronic myeloid leukemia patients in first line treatment with either dasatinib or imatinib for no more than 3 years.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
49 sites in 4 countries.
49 sites in 4 countries
Italy45 sites
S. C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Clinica di Ematologia - Azienda Ospedaliera Regionale di Torrette
Ancona
U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari
Bari
Istituto di Ematologia "L. e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna
USD - Centro Trapianti Midollo Osseo Adulti - Cattedra di Ematologia - Azienda Spedali Civili - Brescia
Brescia
U.O. Ematologia Brindisi- Ospedale A. Perrino ASL BR
Brindisi
CTMO-Ematologia-Ospedale "Binaghi"
Cagliari
U.O. Ematologia CTMO "Businco"
Cagliary
Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto
Catania
Azienda Ospedaliera - Arcispedale S. Anna Sezione di Ematologia e Fisiopatologia delle Emostasi
Ferrara
Divisione di Ematologia - Policlinico Careggi
Florence
Clinica Ematologica - Dipartimento di Medicina Interna - IRCCS San Martino - IST
Genova
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina
Divisione Ematologia - Dipartimento di Medicina Interna -Policlinico Universitario di Messina
Messina
U.O. Ematologia - Azienda USLL12 Veneziana - Ospedale dell'Angelo e Ospedale civile S. Giovanni e Paolo
Mestre - Venezia
U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano
Milan
Dipartimento di Med. Clinica e Sperimentale- Area di Ematologia - Facoltà di Medicina e Chirurgia - Università degli Studi di Napoli "Federico II" -
Naples
U.O. Ematologia - Ospedale S. Gennaro
Naples
XIX Divisione di Ematologia con trapianto - A.O.R.N. "A. Cardarelli"
Naples
Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato"
Novara
Dipartimento di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga
Orbassano
Ematologia ed Immunologia Clinica - Università degli studi di Padova
Padova
Divisione di Ematologia con trapianto di midollo - A.O.U. Policlinico "Paolo Giaccone"
Palermo
U.O.C. Ematologia - A.O. Ospedali Riuniti "Villa Sofia-Cervello"
Palermo
Ematologia e CTMO - A.O.U. Università degli Studi di Parma
Parma
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
Piacenza
U.O. Ematologia - A.O.U. Pisana
Pisa
U.O. Ematologia - A.O. San Carlo
Potenza
Divisione di Ematologia - A.O. Ospedali Riuniti di Reggio Calabria "Bianchi-Melacrino-Morelli"
Reggio Calabria
Rimini Ospedale "Infermi"
Rimini
Department of Onco-Hematology - IRCCS; Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture
Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza"
Roma
Divisione di Ematologia - Ospedale S.Eugenio
Roma
Ematologia - A.O. Sant'Andrea
Roma
Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)
Roma
U.O. di Ematologia - Ente Ospedaliero San Giovanni Addolorata
Roma
U.O.C. Ematologia e Trapianto cellule staminali - Pad Cesalpino- A.O. San Camillo Forlanini
Roma
U.O. di Ematologia - Casa Sollievo della Sofferenza
San Giovanni Rotondo
Ematologia - AOU Sassari
Sassari
U.O.C. Ematologia - A.O. SS Annunziata - P.O.S.G. Moscati
Taranto
S.C. di Oncoematologia - A.O. "S. Maria"
Terni
S.C.D.O. Ematologia II - A.O.U.S. San Giovanni Battista di Torino (Molinette)
Torino
Clinica Ematologica ed Unità di Terapie Cellulari Carlo Melzi - A.O. Universitaria
Udine
Onco-Ematologia - Ospedale S. Andrea- Vercelli
Vercelli
U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona
Verona
Germany2 sites
Universität Heidelberg - III. Medizinische Klinik - Universitätsmedizin Mannheim
Mannheim
Universitat Heidelberg
Mannhein
France1 site
Department of Hematology and Oncology, Hôpital Mignot, Université Versailles Saint-Quentin-en-Yvelines
Le Chesnay
Spain1 site
Department of Hematology, Hospital Universitario de la Princesa
Madrid
About this study
Official title: Mid to Long-term Quality of Life Effects Of imatiNIb Versus DASatinib in Chronic Myeloid Leukemia Patients (LEONIDAS)
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.
Read the 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
- Being tested
- QoL Survey Booklet
- Keywords
- Quality of Life, Chronic Myeloid Leukemia, Imatinib, Dasatinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QoL Survey BookletOther
| Study group | Role | What they receive |
|---|---|---|
| Imatinib | Patients in first line treatment with imatinib for no more than 3 years. Receives: Other: QoL Survey Booklet | |
| Dasatinib | Patients in first line treatment with dasatinib for no more than 3 years. Receives: Other: QoL Survey Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
(outcome measure: EORTC QLQ-C30 and EORTC QLQ-CML24)
Measured: 24 months.
Proportion of patients considered as low, medium and high adheres by type of therapy.
(outcome measure: Morisky-Medication Adherence Scale-MMAS)
Measured: 24 months.
Relationship between patient's perception of disease-/treatment-related information received , QoL profile and adherence to therapy.
(defined according to the EORTC-QLQ-INFO25)
Measured: 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.
(according to the EORTC-QLQ-CML24)
Measured: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study start11 Sep 2014
- Primary completion25 Jan 2017
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Collaborators
- European Leukemia Net, CML Advocates Network
- Responsible party
- Sponsor
- Investigators
- Fabio Efficace, PhD, Study chair, Gruppo Italiano Malattie EMatologiche dell'AdultoGianantonio Rosti, Dr., Study director, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164903
- Sponsor's protocol ID
- QoL-CML0713
- Acronym
- QoL-CML0713
- Status last verified
- Aug 2018
- First submitted
- 27 May 2014
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid to Long-term Quality of Life Effects Of imatiNIb Versus DASatinib in Chronic Myeloid Leukemia Patients (LEONIDAS)
- ClinicalTrials.gov ID
- NCT02164903
- Acronym / sponsor ID
- QoL-CML0713 / QoL-CML0713
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Quality of Life, Chronic Myeloid Leukemia, Imatinib, Dasatinib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Collaborators
- European Leukemia Net, CML Advocates Network
- Study start
- 11 Sep 2014 (actual)
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- Oct 2018 (estimated)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imatinib | – | Other: QoL Survey BookletPatients in first line treatment with imatinib for no more than 3 years. |
| Dasatinib | – | Other: QoL Survey BookletPatients in first line treatment with dasatinib for no more than 3 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult chronic myeloid leukemia patients in first line treatment with either dasatinib or imatinib for no more than 3 years.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QoL Survey Booklet | Other | Dasatinib, Imatinib |
Primary outcome
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.
Time frame: 24 months.
(outcome measure: European Organization for Research and EORTC QLQ-CML24 "Impact on daily life" scale)
4 secondary outcomes
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.
Time frame: 24 months.
Proportion of patients considered as low, medium and high adheres by type of therapy.
Time frame: 24 months.
Relationship between patient's perception of disease-/treatment-related information received , QoL profile and adherence to therapy.
Time frame: 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.
Time frame: 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) FoundationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Efficace, PhD study chair
Gruppo Italiano Malattie EMatologiche dell'Adulto
Gianantonio Rosti, Dr. study director
University of Bologna
49 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 49 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Italy, Germany, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.