Natural History Study of Patients With Chronic Myelogenous Leukemia

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00429910
First received: January 30, 2007
Last updated: July 7, 2009
Last verified: July 2009
  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

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

Resource links provided by NLM:


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
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Jerome Ritz, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00429910     History of Changes
Other Study ID Numbers: CDR0000352370, DFCI-03015
Study First Received: January 30, 2007
Last Updated: July 7, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014