Status:
COMPLETED
Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ 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. Pur...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT00896129
Start Date
March 1 2010
End Date
December 1 2010
Last Update
January 22 2014
Active Locations (25)
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1
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna, Bologna, Italy
2
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
Sassari, Sassari, Italy
3
Nuovo ospedale "Torrette"
Ancona, Italy
4
Unità Operativa Ematologica - Università degli Studi di Bari
Bari, Italy, 70124