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

January 21, 2014 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

448

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Nuovo ospedale "Torrette"
      • Bari, Italy, 70124
        • Unità Operativa Ematologica - Università degli Studi di Bari
      • Bergamo, Italy
        • Ospedali Riuniti
      • Bologna, Italy
        • Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
      • Brescia, Italy, 21125
        • Sezione di Ematologia e Trapianti Spedali Civili
      • Cagliari, Italy, 9121
        • Azienda ASL di Cagliari
      • Catania, Italy, 95124
        • Ospedale Ferrarotto
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliera Pugliese Ciaccio
      • Ferrara, Italy, 44100
        • Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
      • Genova, Italy
        • Clinica Ematologica - Università degli Studi
      • Milano, Italy, 20122
        • Ematologia 1 - Centro Trapianto di Midollo
      • Napoli, Italy, 80131
        • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II"
      • Orbassano, Italy, 10043
        • Ospedale S. Luigi Gonzaga
      • Palermo, Italy, 90146
        • Ospedale Cervello
      • Pescara, Italy, 61100
        • Azienda ASL di Pescara
      • Pisa, Italy, 72100
        • Università di Pisa, Azienda Ospedaliera Pisana
      • Ravenna, Italy, 48100
        • Ospedale S.Maria delle Croci
      • Reggio Calabria, Italy, 85100
        • Ospedali Riuniti - Div. di Ematologia
      • Roma, Italy, 00100
        • Università La Sapienza
      • Roma, Italy
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • Sassari, Italy
        • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
      • Siena, Italy, 53100
        • U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
      • Treviso, Italy, 31100
        • Azienda USL 9 Treviso - U.O. di Ematologia
      • Verona, Italy, 37134
        • Policlinico G.B. Rossi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult CML patiens under Imatinib treatment for at least three years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study population
Other: HRQOL Survey Packet
Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
By the end of the study.

Secondary Outcome Measures

Outcome Measure
Time Frame
Possible association between socio-demographic and clinical variables with patient reported health outcomes.
Time Frame: By the end of the study.
By the end of the study.
Psychological wellbeing.
Time Frame: By the end of the study.
By the end of the study.
Fatigue.
Time Frame: By the end of the study.
By the end of the study.
Adherence to therapy issues.
Time Frame: By the end of the study.
By the end of the study.
Symptom burden.
Time Frame: By the end of the study.
By the end of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Study Chair: Fabio Efficace, PhD, GIMEMA Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

May 8, 2009

First Posted (Estimate)

May 11, 2009

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 21, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QOL-CML0208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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