NCT00429910

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

2.6 years

First QC Date

January 30, 2007

Last Update Submit

December 30, 2016

Conditions

Leukemia

Keywords

accelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (5)

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

    5 years

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

    5 years

  • Health perceptions, symptoms, insurance issues, and work issues

    5 years

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

    5 years

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

    5 years

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic myelogenous leukemia of any phase

Age 18 years and over Diagnosis within one year of enrollment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Study Officials

  • Jerome Ritz, MD

    Dana-Farber Cancer Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jerome M.Ritz MD

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 1, 2007

Study Start

February 1, 2003

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)