Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00896129
First received: May 8, 2009
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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 Intervention
Chronic Myeloid Leukemia
Other: HRQOL Survey Packet

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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.

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychological wellbeing. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Fatigue. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Adherence to therapy issues. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Symptom burden. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Possible association between socio-demographic and clinical variables with patient reported health outcomes. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]

Enrollment: 448
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study population Other: HRQOL Survey Packet
Questionnaires

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult CML patiens under Imatinib treatment for at least three years

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896129

Locations
Italy
Nuovo ospedale "Torrette"
Ancona, Italy
Unità Operativa Ematologica - Università degli Studi di Bari
Bari, Italy, 70124
Ospedali Riuniti
Bergamo, Italy
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna, Italy
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, Italy, 21125
Azienda ASL di Cagliari
Cagliari, Italy, 9121
Ospedale Ferrarotto
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
Genova, Italy
Ematologia 1 - Centro Trapianto di Midollo
Milano, Italy, 20122
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II"
Napoli, Italy, 80131
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, Italy, 80131
Ospedale S. Luigi Gonzaga
Orbassano, Italy, 10043
Ospedale Cervello
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
Roma, Italy
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
Sassari, Italy
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
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Study Chair: Fabio Efficace, PhD GIMEMA Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00896129     History of Changes
Other Study ID Numbers: QOL-CML0208
Study First Received: May 8, 2009
Last Updated: January 21, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Health Outcomes Research
CML

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014