Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
2 other identifiers
observational
3,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 8, 2005
CompletedFirst Submitted
Initial submission to the registry
December 30, 2008
CompletedFirst Posted
Study publicly available on registry
December 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2030
April 16, 2026
April 1, 2026
24.9 years
December 30, 2008
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CML Patient Response to standard dose imatinib treated outside clinical trial setting
June 2012
Secondary Outcomes (2)
Number of chromosomal abnormalities incidences in Ph-negative metaphases associated with imatinib treatment in CML patients treated with standard dose outside clinical trial setting
June 2012
Outcome of conception + pregnancy during imatinib treatment in CML patients
June 2012
Study Arms (1)
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Assi R, Kantarjian H, Keating M, Pemmaraju N, Verstovsek S, Garcia-Manero G, Ravandi F, Borthakur G, Dahl J, Jabbour E, Cortes JE. Management of chronic myeloid leukemia during pregnancy among patients treated with a tyrosine kinase inhibitor: a single-Center experience. Leuk Lymphoma. 2021 Apr;62(4):909-917. doi: 10.1080/10428194.2020.1849672. Epub 2020 Dec 7.
PMID: 33283580DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Koji Sasaki, M.D.
M.D. Anderson Cancer Center
Central Study Contacts
Sasaki
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2008
First Posted
December 31, 2008
Study Start
June 8, 2005
Primary Completion (Estimated)
April 30, 2030
Study Completion (Estimated)
April 30, 2030
Last Updated
April 16, 2026
Record last verified: 2026-04