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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014