Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
In this study investigators propose to do a chart review of all Chronic Myelogenous Leukemia (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:
- It represents a very large patient population receiving standard-dose therapy with imatinib. Estimate over 200 patients evaluated and fall in this category.
- The follow-up for patients in the largest trial using standard-dose imatinib (the IRIS trial, with 553 patients in treated with imatinib) has been limited after the first 12 months. For example, the rate of molecular responses after the first 12 months of therapy was not obtained as samples stopped being collected at that time point.
- Patients who are or become pregnant during therapy with imatinib have not been eligible for clinical trials with imatinib or had to be taken off study. Thus, there is no information on the effect of imatinib on imatinib on pregnancy and conception, several such patients have been followed at MDACC.
- This is a patient population that follows therapy mostly as directed by their local oncologists. This is frequently less stringently adhered to the recommended guidelines for imatinib therapy, with more frequent treatment interruptions, and frequently using suboptimal doses of imatinib (i.e., less than 300mg daily). The effect of these treatment interruptions and suboptimal dosing on response and development of resistance is unclear.
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial|
- CML Patient Response to standard dose imatinib treated outside clinical trial setting [ Time Frame: June 2012 ] [ Designated as safety issue: No ]
- Number of chromosomal abnormalities incidences in Ph-negative metaphases associated with imatinib treatment in CML patients treated with standard dose outside clinical trial setting [ Time Frame: June 2012 ] [ Designated as safety issue: No ]
- Outcome of conception + pregnancy during imatinib treatment in CML patients [ Time Frame: June 2012 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
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.
Other: Chart Review
Investigator review of MDACC CML patient charts.
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.
The following information will be collected:
- Demographic information including age, gender, ethnicity, education, and work history.
- All laboratory values obtained at MDACC or other institutions, including CBC, blood chemistries, electrolytes, bone marrow aspirations and biopsies, cytogenetic analyses, FISH, and PCR.
- Treatment history including starting and stopping dates, doses, treatment interruptions, dose changes and reasons for dose modifications.
- Information about toxicity including type, grade, dates of onset and resolution, interventions to manage toxicity, and sequelae.
- Information regarding pregnancy or conception during imatinib therapy for both male and female patients, including dates of pregnancy, outcome of pregnancy, interventions during pregnancy, management of CML during pregnancy, complications during pregnancy, status of the product, condition of the born child, and information on lactation.
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.
Approximately 850 charts will be reviewed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816114
|Contact: Jorge Cortes, M.D.||email@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jorge Cortes, M.D. 713-794-5783 firstname.lastname@example.org|
|Principal Investigator: Jorge Cortes, M.D.|
|Principal Investigator:||Jorge Cortes, M.D.||M.D. Anderson Cancer Center|