Natural History Study of Patients With Chronic Myelogenous Leukemia

Completed

• Conditions: Leukemia

• Registration Number: NCT00429910
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 2003-02
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2007-01-30
• Study First Submitted QC: 2007-01-30
• Study First Posted: 2007-02-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-30
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of current procedures for diagnosis, management, and follow-up on disease status	5 years
Natural history of patients with chronic myelogenous leukemia who achieve response to imatinib mesylate	5 years
Health perceptions, symptoms, insurance issues, and work issues	5 years
Affect of medication compliance and planned dose reduction on imatinib mesylate effectiveness	5 years
Molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate	5 years

Trial Locations

Locations (1)

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States