Clinical trial NCT00896129: Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukemia
Keywords: Health Outcomes Research
CML
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2009-05-11
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult CML patiens under Imatinib treatment for at least three years

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: By the end of the study.
Secondary outcomes:
measure: Psychological wellbeing.
timeFrame: By the end of the study.
measure: Fatigue.
timeFrame: By the end of the study.
measure: Adherence to therapy issues.
timeFrame: By the end of the study.
measure: Symptom burden.
timeFrame: By the end of the study.
measure: Possible association between socio-demographic and clinical variables with patient reported health outcomes.
timeFrame: By the end of the study.
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Nuovo ospedale "Torrette"
city: Bari
country: Italy
facility: Unità Operativa Ematologica - Università degli Studi di Bari
city: Bergamo
country: Italy
facility: Ospedali Riuniti
city: Bologna
country: Italy
facility: Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
city: Brescia
country: Italy
facility: Sezione di Ematologia e Trapianti Spedali Civili
city: Cagliari
country: Italy
facility: Azienda ASL di Cagliari
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Pugliese Ciaccio
city: Ferrara
country: Italy
facility: Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
city: Genova
country: Italy
facility: Clinica Ematologica - Università degli Studi
city: Milano
country: Italy
facility: Ematologia 1 - Centro Trapianto di Midollo
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II"
city: Orbassano
country: Italy
facility: Ospedale S. Luigi Gonzaga
city: Palermo
country: Italy
facility: Ospedale Cervello
city: Pescara
country: Italy
facility: Azienda ASL di Pescara
city: Pisa
country: Italy
facility: Università di Pisa, Azienda Ospedaliera Pisana
city: Ravenna
country: Italy
facility: Ospedale S.Maria delle Croci
city: Reggio Calabria
country: Italy
facility: Ospedali Riuniti - Div. di Ematologia
city: Roma
country: Italy
facility: Università La Sapienza
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
city: Sassari
country: Italy
facility: Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
city: Siena
country: Italy
facility: U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
city: Treviso
country: Italy
facility: Azienda USL 9 Treviso - U.O. di Ematologia
city: Verona
country: Italy
facility: Policlinico G.B. Rossi
Study officials:
affiliation: GIMEMA Foundation
name: Fabio Efficace, PhD
role: STUDY_CHAIR
References:
citation: 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.