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Chronic Myeloid Leukemia (CML) Cohort


N/A
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Chronic Myeloid Leukemia (CML) Cohort


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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

Principal Investigator

Jerome Ritz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000352370

NCT ID:

NCT00429910

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115