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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00896129
Other study ID # QOL-CML0208
Secondary ID
Status Completed
Phase N/A
First received May 8, 2009
Last updated January 21, 2014
Start date March 2010
Est. completion date December 2010

Study information

Verified date January 2014
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

OBJECTIVES:

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.


Recruitment information / eligibility

Status Completed
Enrollment 448
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
HRQOL Survey Packet
Questionnaires

Locations

Country Name City State
Italy Nuovo ospedale "Torrette" Ancona
Italy Unità Operativa Ematologica - Università degli Studi di Bari Bari
Italy Ospedali Riuniti Bergamo
Italy Ist.Ematologia e Oncologia Medica L.e A. Seragnoli Bologna
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 Milano
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 Cattolica del Sacro Cuore - Policlinico A. Gemelli Roma
Italy Università La Sapienza Roma
Italy Serv. di Ematologia Ist. di Ematologia ed Endocrinologia Sassari
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

Sponsors (1)

Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Efficace F, Baccarani M, Breccia M, Alimena G, Rosti G, Cottone F, Deliliers GL, Baratè 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Psychological wellbeing. By the end of the study.
Secondary Fatigue. By the end of the study.
Secondary Adherence to therapy issues. By the end of the study.
Secondary Symptom burden. By the end of the study.
Secondary Possible association between socio-demographic and clinical variables with patient reported health outcomes. By the end of the study.
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