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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00816114 |
In this study investigators propose to do a chart review of all CML patients that are treated outside of a clinical trial with imatinib that come to MDACC for a second opinion. This is an important population of patients that differs in their management from patients treated in clinical trials for several reasons including but not limited to:
Investigators thus plan to conduct a chart review of these patients to study their treatment course before their initial evaluation at MDACC, and between and during visits to MDACC.
Condition | Intervention |
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Chronic Myelogenous Leukemia |
Other: Chart Review |
Study Type: | Observational |
Study Design: | Case Control, Retrospective |
Official Title: | Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial |
Estimated Enrollment: | 850 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Chronic Myelogenous Leukemia
All CML patients in any phase of the disease that received imatinib treatment outside of MDACC clinical trials and has had at least one MDACC clinic visit.
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Other: Chart Review
Investigator review of MDACC CML patient charts.
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PATIENT POPULATION:
All patients with CML in any phase of the disease (chronic, accelerated or blast phase) that has received treatment with imatinib not on an MDACC clinical trial regardless of prior treatment history, and has had at least one clinic visit at MDACC will be eligible.
STUDY PLAN:
The following information will be collected:
This information will be reviewed from the documents received as part of the routine communication with the local oncologist or from the studies obtained at MDACC.
There will be no treatment changes or recommendations as a result of this study. This study will be strictly limited to review of charts. Patients will continue their treatment as recommended by their local oncologist and treating physician at MDACC.
These results will be compared to similar patients treated with imatinib in the context of clinical trials both from published literature and from studies conducted at MDACC. The response rates, duration of response, toxicity, dose intensity, and rate of transformation will be compared.
Investigators will review data from July 1, 1998 to October 31, 2008.
SAMPLE SIZE:
Approximately 850 charts will be reviewed.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
MDACC CML patients (from July 1, 1998 to October 31, 2008) in any disease phase (chronic, accelerated or blast phase) that received imatinib treatment outside an MDACC clinical trial prior to a MCACC clinic visit.
Inclusion Criteria:
Exclusion Criteria:
Contact: Jorge Cortes, M.D. | 713-794-5783 | jcortes@mdanderson.org |
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Jorge Cortes, M.D. 713-794-5783 jcortes@mdanderson.org | |
Principal Investigator: Jorge Cortes, M.D. |
Principal Investigator: | Jorge Cortes, M.D. | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Jorge Cortes, M.D./Professor ) |
Study ID Numbers: | RCR05-0444 |
Study First Received: | December 30, 2008 |
Last Updated: | May 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00816114 History of Changes |
Health Authority: | United States: Institutional Review Board |
Imatinib Gleevec Chronic Myelogenous Leukemia CML |
Imatinib Leukemia Hematologic Diseases Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
Chronic Myelogenous Leukemia Leukemia, Myeloid Bone Marrow Diseases Protein Kinase Inhibitors |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Protein Kinase Inhibitors |
Pharmacologic Actions Imatinib Leukemia Neoplasms Therapeutic Uses Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases |