Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
1 other identifier
observational
448
1 country
25
Brief Summary
Rationale: At present, virtually no evidence exists regarding mid to long-term patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients treated with Imatinib. Purpose: the results of this research will provide preliminary evidence-based data on an number of issues from the patients' perspective, including adherence to therapy issues.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Shorter than P25 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2009
CompletedFirst Posted
Study publicly available on registry
May 11, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 22, 2014
January 1, 2014
9 months
May 8, 2009
January 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy.
By the end of the study.
Secondary Outcomes (5)
Psychological wellbeing.
By the end of the study.
Fatigue.
By the end of the study.
Adherence to therapy issues.
By the end of the study.
Symptom burden.
By the end of the study.
Possible association between socio-demographic and clinical variables with patient reported health outcomes.
By the end of the study.
Study Arms (1)
Study population
Interventions
Eligibility Criteria
Adult CML patiens under Imatinib treatment for at least three years
You may qualify if:
- Age 18 years.
- CML patients meeting the following criteria:
- Started IM therapy in the early chronic phase (ECP).
- Have been undergoing treatment with IM, as first line therapy, for at least three years regardless of the current prescribed dose of IM.
- In complete cytogenetic response (CCgR) and no clinical evidence of disease progression to accelerated phase (AP) or blast crisis (BC).
- Able to read and write Italian.
- Freedom from psychiatric conditions that may confound HRQOL evaluation.
- Informed consent provided.
You may not qualify if:
- CML patients who were initially diagnosed in the AP or BC or those who started therapy with IM in the late chronic phase (LCP).
- Having received any kind of treatment prior to IM therapy (except for hydroxyurea and/or anagrelide).
- Patients with a new primary malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna, Bologna, Italy
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
Sassari, Sassari, Italy
Nuovo ospedale "Torrette"
Ancona, Italy
Unità Operativa Ematologica - Università degli Studi di Bari
Bari, 70124, Italy
Ospedali Riuniti
Bergamo, Italy
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, 21125, Italy
Azienda ASL di Cagliari
Cagliari, 9121, Italy
Ospedale Ferrarotto
Catania, 95124, Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, 88100, Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, 44100, Italy
Clinica Ematologica - Università degli Studi
Genova, Italy
Ematologia 1 - Centro Trapianto di Midollo
Milan, 20122, Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, 80131, Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II"
Napoli, 80131, Italy
Ospedale S. Luigi Gonzaga
Orbassano, 10043, Italy
Ospedale Cervello
Palermo, 90146, Italy
Azienda ASL di Pescara
Pescara, 61100, Italy
Università di Pisa, Azienda Ospedaliera Pisana
Pisa, 72100, Italy
Ospedale S.Maria delle Croci
Ravenna, 48100, Italy
Ospedali Riuniti - Div. di Ematologia
Reggio Calabria, 85100, Italy
Università La Sapienza
Roma, 00100, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena, 53100, Italy
Azienda USL 9 Treviso - U.O. di Ematologia
Treviso, 31100, Italy
Policlinico G.B. Rossi
Verona, 37134, Italy
Related Publications (1)
Efficace F, Baccarani M, Breccia M, Alimena G, Rosti G, Cottone F, Deliliers GL, Barate C, Rossi AR, Fioritoni G, Luciano L, Turri D, Martino B, Di Raimondo F, Dabusti M, Bergamaschi M, Leoni P, Simula MP, Levato L, Ulisciani S, Veneri D, Sica S, Rambaldi A, Vignetti M, Mandelli F; GIMEMA. Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population. Blood. 2011 Oct 27;118(17):4554-60. doi: 10.1182/blood-2011-04-347575. Epub 2011 Jul 12.
PMID: 21750313BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fabio Efficace, PhD
GIMEMA Foundation
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2009
First Posted
May 11, 2009
Study Start
March 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 22, 2014
Record last verified: 2014-01