LeukemiaNCT00429910
Natural History Study of Patients With Chronic Myelogenous Leukemia
An observational study of Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Leukemia
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Sep 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic myelogenous leukemia of any phase
Age 18 years and over Diagnosis within one year of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Chronic Myeloid Leukemia (CML) Cohort
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.
Read the 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.
- Conditions
- Leukemia
- Keywords
- accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, meningeal chronic myelogenous leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Accelerated Phase, Blast Crisis, Leukemia, Myeloid, Chronic-Phase
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of current procedures for diagnosis, management, and follow-up on disease status
Measured: 5 years
Natural history of patients with chronic myelogenous leukemia who achieve response to imatinib mesylate
Measured: 5 years
Health perceptions, symptoms, insurance issues, and work issues
Measured: 5 years
Affect of medication compliance and planned dose reduction on imatinib mesylate effectiveness
Measured: 5 years
Molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startFeb 2003
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jerome Ritz, MD, Dana-Farber Cancer Institute
- Investigators
- Jerome Ritz, MD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429910
- Sponsor's protocol ID
- 03-015
- Other IDs
- P30CA006516, CDR0000352370
- Status last verified
- Dec 2016
- First submitted
- 30 Jan 2007
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Myeloid Leukemia (CML) Cohort
- ClinicalTrials.gov ID
- NCT00429910
- Acronym / sponsor ID
- 03-015
- Conditions
- Leukemia
- Keywords
- accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, meningeal chronic myelogenous leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic myelogenous leukemia of any phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome Ritz, MD study chair
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of current procedures for diagnosis, management, and follow-up on disease status (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2017.