Natural History Study of Patients With Chronic Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00429910|
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : January 2, 2017
RATIONALE: Gathering information about patients with chronic myelogenous leukemia may help doctors learn more about the disease and find better methods of treatment and on-going care.
PURPOSE: This natural history study is collecting health information and disease-related information over time from patients with newly diagnosed chronic myelogenous leukemia.
|Condition or disease|
- Determine the impact of current procedures for diagnosis, management, and follow-up on disease status of patients with newly diagnosed chronic myelogenous leukemia (CML).
- Determine the natural history of patients with CML who achieve response to imatinib mesylate.
- Determine the health perceptions, symptoms, insurance issues, and work issues of these patients.
- Determine whether medication compliance and planned dose reduction affect imatinib mesylate effectiveness in these patients.
- Determine the molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate in these patients.
OUTLINE: This is a longitudinal, prospective, cohort study.
Patients complete quality of life, functional status, medical and treatment history, and medication questionnaires at baseline and then every 6 months for 5 years.
Blood samples are collected at baseline and then every 6 months for 5 years. Specimens may be examined in the future in gene array studies and mutation analyses.
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|Official Title:||Chronic Myeloid Leukemia (CML) Cohort|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||September 2005|
- Impact of current procedures for diagnosis, management, and follow-up on disease status [ Time Frame: 5 years ]
- Natural history of patients with chronic myelogenous leukemia who achieve response to imatinib mesylate [ Time Frame: 5 years ]
- Health perceptions, symptoms, insurance issues, and work issues [ Time Frame: 5 years ]
- Affect of medication compliance and planned dose reduction on imatinib mesylate effectiveness [ Time Frame: 5 years ]
- Molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429910
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Jerome Ritz, MD||Dana-Farber Cancer Institute|