Natural History Study of Patients With Chronic Myelogenous Leukemia

Leukemia Clinical Trial

Official title:

Chronic Myeloid Leukemia (CML) Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429910
• Other study ID #: 03-015
• Secondary ID: P30CA006516CDR00
• Status: Completed
• Phase: N/A
• First received: January 30, 2007
• Last updated: December 30, 2016
• Start date: February 2003
• Est. completion date: September 2005

Study information

• Verified date: December 2016
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years
• Eligibility: Age 18 years and over Diagnosis within one year of enrollment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of current procedures for diagnosis, management, and follow-up on disease status		5 years	No
Primary	Natural history of patients with chronic myelogenous leukemia who achieve response to imatinib mesylate		5 years	No
Primary	Health perceptions, symptoms, insurance issues, and work issues		5 years	No
Primary	Affect of medication compliance and planned dose reduction on imatinib mesylate effectiveness		5 years	No
Primary	Molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate		5 years	No