Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/25/2018 |
Start Date: | December 2, 2010 |
End Date: | August 30, 2020 |
Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)
The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI)
in patients newly diagnosed with CML and their quality of life in a real-world setting.
in patients newly diagnosed with CML and their quality of life in a real-world setting.
Time Perspective : Most patients are expected to be a mix of retrospective and prospective
data collection. Patients can be enrolled after their study index date (retrospective
component) and have to be followed until 5 years from study index date are complete (time
between enrollment and 5 year follow-up is the prospective component)
data collection. Patients can be enrolled after their study index date (retrospective
component) and have to be followed until 5 years from study index date are complete (time
between enrollment and 5 year follow-up is the prospective component)
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.
Inclusion Criteria:
- Newly-diagnosed chronic phase chronic myeloid leukemia (CP-CML) patients who started
their first-line Tyrosine Kinase Inhibitor (TKI) treatment on imatinib, dasatinib or
nilotinib in accordance with the timelines below
- 18 years or older at time of of CP-CML diagnosis
a) Imatinib Cohorts
- Patients who started their first-line Imatinib treatment between January 2, 2008 and
September 30, 2010.Patients fitting this criterion are defined as retrospective
Imatinib patients
− Patients who started their first-line Imatinib treatment on or after October 1, 2010
b) Dasatinib Cohort
- Patients who started their first-line Dasatinib treatment after the drug was approved
in this indication
c) Nilotinib Cohort
- Patients who started their first-line Nilotinib treatment after the drug was approved
in this indication
- Patients are also eligible when they have already switched to a subsequent therapy
(TKI or other) at the time of enrollment, as long as their first-line and subsequent
CML treatment information is available at site for data entry into the study
Electronic Case Report Form (eCRF)
- Receiving treatment at medical practice (eg. community-based, office-based,
hospital-based, academic setting, oncology center)
Exclusion Criteria:
- Patients who are participating in an interventional trial which may influence the
management of their CML disease will be excluded
Discontinuation Criteria:
- Enrolled patients who join an interventional trial which may influence the management
of their CML disease will be excluded at the time of entry into the interventional
trial
We found this trial at
144
sites
University of Southern California The University of Southern California is one of the world’s leading...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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105 West 8th Avenue
Spokane, Washington 99220
Spokane, Washington 99220
(509) 474-3131
Providence Cancer Center at Sacred Heart Medical Center When Mother Joseph and the Sisters of...
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Wenatchee Valley Medical Center Established on July 21, 2013, Confluence Health is an affiliation between...
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Akron General Medical Center It
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Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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St Luke'S Hospital And Health Network St. Luke's University Health Network (SLUHN) is a nonprofit,...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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