Clinical trial NCT00429910: Natural History Study of Patients With Chronic Myelogenous Leukemia
Official title: Chronic Myeloid Leukemia (CML) Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-02-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic myelogenous leukemia of any phase

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.

Eligibility criteria: Age 18 years and over Diagnosis within one year of enrollment

Primary outcomes:
measure: Impact of current procedures for diagnosis, management, and follow-up on disease status
timeFrame: 5 years
measure: Natural history of patients with chronic myelogenous leukemia who achieve response to imatinib mesylate
timeFrame: 5 years
measure: Health perceptions, symptoms, insurance issues, and work issues
timeFrame: 5 years
measure: Affect of medication compliance and planned dose reduction on imatinib mesylate effectiveness
timeFrame: 5 years
measure: Molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jerome Ritz, MD
role: STUDY_CHAIR
References: