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Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial

This study is currently recruiting participants.
Verified October 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816114
First Posted: December 31, 2008
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

In this study researchers propose to do a chart review of all patients that are treated outside of a clinical trial with imatinib, dasatinib, nilotinib, or any other tyrosine kinase inhibitor that becomes FDA approved for the managements of CML 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:

  1. It represents a very large patient population receiving standard-dose therapy with TKI. We estimate that we have evaluated over 300 patients that fall in this category.
  2. 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.
  3. Registration studies for dasatinib and nilotinib have similar limitations with limited follow-up and available information coming only from databases from the sponsors to which there is limited access to investigate dosing, chronic toxicities, second malignancies and other important aspects of therapy.
  4. Patients who are or become pregnant during therapy with TKI have not been eligible for clinical trials with TKI or had to be taken off study. Thus, there is no information on the effect of TKI on imatinib on pregnancy and conception. We have followed several such patients at MDACC.
  5. 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 TKI 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.

Researchers 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
Chronic Myelogenous Leukemia Other: Chart Review

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • CML Patient Response to standard dose imatinib treated outside clinical trial setting [ Time Frame: June 2012 ]

Secondary Outcome Measures:
  • 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 ]
  • Outcome of conception + pregnancy during imatinib treatment in CML patients [ Time Frame: June 2012 ]

Estimated Enrollment: 3000
Actual Study Start Date: June 2005
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

PATIENT POPULATION:

All patients with CML in any phase of the disease (chronic, accelerated or blast phase) that has received treatment with any tyrosine kinase inhibitor (eg, imatinib, dasatinib, nilotinib) regardless of prior treatment history that has had at least one clinic visit at MDACC will be eligible.

STUDY PLAN:

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, mutation analysis, FISH, and PCR, and other tests obtained during regular care of these patients.
  • 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 other studies conducted at MDACC. The efficacy, safety and prognostic markers will be compared.
  • We will review data from July 1, 1998 to September 1, 2017.

SAMPLE SIZE:

Approximately 3000 charts will be reviewed.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MDACC CML patients (July 1, 1998 to September 1, 2017) in any disease phase (chronic, accelerated or blast phase) that received imatinib treatment outside an MDACC clinical trial prior to a MCACC clinic visit.
Criteria

Inclusion Criteria:

All patients with CML in any phase of the disease (chronic, accelerated or blast phase) that has received treatment with any FDA-approved tyrosine kinase inhibitor (eg, imatinib, dasatinib, nilotinib) not on an MDACC clinical trial regardless of prior treatment history that has had at least one clinic visit at MDACC will be eligible.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816114


Contacts
Contact: Jorge Cortes, M.D. 713-794-5783 jcortes@mdanderson.org

Locations
United States, Texas
University of Texas MD 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.         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jorge Cortes, M.D. M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00816114     History of Changes
Other Study ID Numbers: RCR05-0444
First Submitted: December 30, 2008
First Posted: December 31, 2008
Last Update Posted: October 27, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Imatinib
Gleevec
Chronic Myelogenous Leukemia
CML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action