Know Cancer

or
forgot password

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


N/A
N/A
N/A
Open (Enrolling)
Both
Chronic Myelogenous Leukemia

Thank you

Trial Information

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


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:

- 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.

SAMPLE SIZE:

Approximately 850 charts will be reviewed.


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:

N/A

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

CML Patient Response to standard dose imatinib treated outside clinical trial setting

Outcome Time Frame:

June 2012

Safety Issue:

No

Principal Investigator

Jorge Cortes, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

RCR05-0444

NCT ID:

NCT00816114

Start Date:

June 2005

Completion Date:

June 2014

Related Keywords:

  • Chronic Myelogenous Leukemia
  • Imatinib
  • Gleevec
  • Chronic Myelogenous Leukemia
  • CML
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030