Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
NCT ID: NCT00896129
Last Updated: 2014-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
448 participants
OBSERVATIONAL
2010-03-31
2010-12-31
Brief Summary
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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.
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Detailed Description
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Primary: to investigate a 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.
Secondary evaluation of:
* Psychological wellbeing.
* Fatigue.
* Adherence to therapy issues.
* Symptom burden.
* Possible association between social-demographic and clinical variables with patient reported health outcomes.
OUTLINE:This is a multicenter study.
SAMPLE SIZE:
Sample size estimation has not been performed considering the nature of the study and the lack of preliminary data to hypothesize the number of possible eligible patients in each center.
DURATION OF THE STUDY:
The recruitment period is estimated in approximately 6 to 12 months.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Study population
HRQOL Survey Packet
Questionnaires
Interventions
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HRQOL Survey Packet
Questionnaires
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Having received any kind of treatment prior to IM therapy (except for hydroxyurea and/or anagrelide).
* Patients with a new primary malignancy.
18 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Fabio Efficace, PhD
Role: STUDY_CHAIR
GIMEMA Foundation
Locations
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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, , Italy
Ospedali Riuniti
Bergamo, , Italy
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, , Italy
Azienda ASL di Cagliari
Cagliari, , Italy
Ospedale Ferrarotto
Catania, , Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, , Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, , Italy
Clinica Ematologica - Università degli Studi
Genova, , Italy
Ematologia 1 - Centro Trapianto di Midollo
Milan, , Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, , Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II"
Napoli, , Italy
Ospedale S. Luigi Gonzaga
Orbassano, , Italy
Ospedale Cervello
Palermo, , Italy
Azienda ASL di Pescara
Pescara, , Italy
Università di Pisa, Azienda Ospedaliera Pisana
Pisa, , Italy
Ospedale S.Maria delle Croci
Ravenna, , Italy
Ospedali Riuniti - Div. di Ematologia
Reggio Calabria, , Italy
Università La Sapienza
Roma, , Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, , Italy
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Azienda USL 9 Treviso - U.O. di Ematologia
Treviso, , Italy
Policlinico G.B. Rossi
Verona, , Italy
Countries
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References
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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.
Related Links
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Related Info
Other Identifiers
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QOL-CML0208
Identifier Type: -
Identifier Source: org_study_id
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