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Natural History Study of Patients With Chronic Myelogenous Leukemia

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2007

Sponsored by: Dana-Farber Cancer Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00429910
  Purpose

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 Intervention
Leukemia
Procedure: quality-of-life assessment

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Chronic Myeloid Leukemia (CML) Cohort

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment:   2000
Study Start Date:   February 2003

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.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study within 2 years.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed chronic myelogenous leukemia

    • Any phase of disease allowed

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429910

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute     Recruiting
      Boston, Massachusetts, United States, 02115
      Contact: Clinical Trials Office - Dana-Farber/Harvard Cancer Center     617-582-8480        

Sponsors and Collaborators
Dana-Farber Cancer Institute

Investigators
Study Chair:     Jerome Ritz, MD     Dana-Farber Cancer Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000352370, DFCI-03015
First Received:   January 30, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00429910
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
accelerated phase chronic myelogenous leukemia  
blastic phase chronic myelogenous leukemia  
chronic phase chronic myelogenous leukemia  
meningeal chronic myelogenous leukemia  

Study placed in the following topic categories:
Blast Crisis
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Leukemia, Myeloid, Accelerated Phase
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 03, 2008




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