Chronic Myelogenous LeukemiaNCT00816114
Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
An observational study of Chronic Myelogenous Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Myelogenous Leukemia
- What is being tested?
- Chart Review
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2005to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sasaki contact
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Koji Sasaki, M.D., 713-745-2882, ksasaki1@mdanderson.org
Koji Sasaki, M.D.
About this study
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:
- 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.
- 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.
- 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.
- 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.
- 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.
Read the 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 August 1, 2019.
SAMPLE SIZE:
Approximately 3000 charts will be reviewed.
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- Chart Review
- Keywords
- Imatinib, Gleevec, Chronic Myelogenous Leukemia, CML
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chart ReviewOther
Investigator review of MDACC CML patient charts.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
CML Patient Response to standard dose imatinib treated outside clinical trial setting
Measured: 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
Measured: June 2012
Outcome of conception + pregnancy during imatinib treatment in CML patients
Measured: June 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study start8 Jun 2005
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Koji Sasaki, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816114
- Sponsor's protocol ID
- RCR05-0444
- Other IDs
- NCI-2021-13238
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2008
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33283580
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
- ClinicalTrials.gov ID
- NCT00816114
- Acronym / sponsor ID
- RCR05-0444
- Conditions
- Chronic Myelogenous Leukemia
- Keywords
- Imatinib, Gleevec, Chronic Myelogenous Leukemia, CML
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 8 Jun 2005 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 31 Dec 2008 (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.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
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 August 1, 2019.
SAMPLE SIZE:
Approximately 3000 charts will be reviewed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Myelogenous Leukemia | – | Other: Chart ReviewAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chart ReviewInvestigator review of MDACC CML patient charts. | Other | Chronic Myelogenous Leukemia |
Primary outcome
CML Patient Response to standard dose imatinib treated outside clinical trial setting
Time frame: June 2012
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 33283580Assi 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.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Sasaki contact
Koji Sasaki, M.D. principal investigator
M.D. Anderson Cancer Center
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 Chronic Myelogenous Leukemia, run by M.D. Anderson Cancer Center 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koji Sasaki, M.D. ((713) 745-2882, ksasaki1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CML Patient Response to standard dose imatinib treated outside clinical trial setting (time frame: June 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00816114, which also lists 1 linked publication.
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 7 Oct 2026.