Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00896129|
Recruitment Status : Completed
First Posted : May 11, 2009
Last Update Posted : January 22, 2014
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.
|Condition or disease||Intervention/treatment|
|Chronic Myeloid Leukemia||Other: HRQOL Survey Packet|
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.
- 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 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.
|Study Type :||Observational|
|Actual Enrollment :||448 participants|
|Official Title:||Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia Patients With Complete Cytogenetic Response Treated With Imatinib as First Line Therapy: Health-Related Quality of Life, Symptom Burden and Adherence to Therapy Issues.|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Other: HRQOL Survey Packet
- 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. [ Time Frame: By the end of the study. ]
- Psychological wellbeing. [ Time Frame: By the end of the study. ]
- Fatigue. [ Time Frame: By the end of the study. ]
- Adherence to therapy issues. [ Time Frame: By the end of the study. ]
- Symptom burden. [ Time Frame: By the end of the study. ]
- Possible association between socio-demographic and clinical variables with patient reported health outcomes. [ Time Frame: By the end of the study. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896129
|Nuovo ospedale "Torrette"|
|Unità Operativa Ematologica - Università degli Studi di Bari|
|Bari, Italy, 70124|
|Ist.Ematologia e Oncologia Medica L.e A. Seragnoli|
|Sezione di Ematologia e Trapianti Spedali Civili|
|Brescia, Italy, 21125|
|Azienda ASL di Cagliari|
|Cagliari, Italy, 9121|
|Catania, Italy, 95124|
|Azienda Ospedaliera Pugliese Ciaccio|
|Catanzaro, Italy, 88100|
|Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna|
|Ferrara, Italy, 44100|
|Clinica Ematologica - Università degli Studi|
|Ematologia 1 - Centro Trapianto di Midollo|
|Milano, Italy, 20122|
|Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"|
|Napoli, Italy, 80131|
|Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II"|
|Napoli, Italy, 80131|
|Ospedale S. Luigi Gonzaga|
|Orbassano, Italy, 10043|
|Palermo, Italy, 90146|
|Azienda ASL di Pescara|
|Pescara, Italy, 61100|
|Università di Pisa, Azienda Ospedaliera Pisana|
|Pisa, Italy, 72100|
|Ospedale S.Maria delle Croci|
|Ravenna, Italy, 48100|
|Ospedali Riuniti - Div. di Ematologia|
|Reggio Calabria, Italy, 85100|
|Università La Sapienza|
|Roma, Italy, 00100|
|Università Cattolica del Sacro Cuore - Policlinico A. Gemelli|
|Serv. di Ematologia Ist. di Ematologia ed Endocrinologia|
|U.O. Ematologia, Azienda Ospedaliera Universitaria Senese|
|Siena, Italy, 53100|
|Azienda USL 9 Treviso - U.O. di Ematologia|
|Treviso, Italy, 31100|
|Policlinico G.B. Rossi|
|Verona, Italy, 37134|
|Study Chair:||Fabio Efficace, PhD||GIMEMA Foundation|