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Natural History Study of Patients With Chronic Myelogenous Leukemia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jerome Ritz, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00429910
First received: January 30, 2007
Last updated: December 30, 2016
Last verified: December 2016
  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
Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Myeloid Leukemia (CML) Cohort

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Impact of current procedures for diagnosis, management, and follow-up on disease status [ Time Frame: 5 years ]
  • Natural history of patients with chronic myelogenous leukemia who achieve response to imatinib mesylate [ Time Frame: 5 years ]
  • Health perceptions, symptoms, insurance issues, and work issues [ Time Frame: 5 years ]
  • Affect of medication compliance and planned dose reduction on imatinib mesylate effectiveness [ Time Frame: 5 years ]
  • Molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate [ Time Frame: 5 years ]

Enrollment: 48
Study Start Date: February 2003
Study Completion Date: September 2005
Primary Completion Date: September 2005 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic myelogenous leukemia of any phase
Criteria
Age 18 years and over Diagnosis within one year of enrollment
  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
National Cancer Institute (NCI)
Investigators
Study Chair: Jerome Ritz, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Jerome Ritz, MD, Jerome M.Ritz MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00429910     History of Changes
Other Study ID Numbers: 03-015
P30CA006516 ( US NIH Grant/Contract Award Number )
CDR0000352370
Study First Received: January 30, 2007
Last Updated: December 30, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Dana-Farber Cancer Institute:
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 May 22, 2017