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Completed

NCT Number: NCT00429910

Natural History Study of Patients With Chronic Myelogenous Leukemia

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.

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Key information

Conditions

Leukemia Blast Crisis Bone Marrow Diseases Carcinogenesis Cell Transformation, Neoplastic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Chronic-Phase Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Age 18 years and over Diagnosis within one year of enrollment

Treatment and study plan

Primary outcomes

  1. Impact of current procedures for diagnosis, management, and follow-up on disease status

    Time frame: 5 years

  2. Natural history of patients with chronic myelogenous leukemia who achieve response to imatinib mesylate

    Time frame: 5 years

  3. Health perceptions, symptoms, insurance issues, and work issues

    Time frame: 5 years

  4. Affect of medication compliance and planned dose reduction on imatinib mesylate effectiveness

    Time frame: 5 years

  5. Molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Chronic Myeloid Leukemia (CML) Cohort

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Feb 1, 2007
Registry last updated
Jan 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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