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

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Completed

Conditions: Chronic Myeloid Leukemia

Treatments: Other: HRQOL Survey Packet

Study type: Observational

Funder types: Other

Identifiers

NCT00896129

QOL-CML0208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 448 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

448 participants in 1 patient group

Study population

Treatment:

Other: HRQOL Survey Packet