Brief Summary
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.
Brief Title
Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting
Detailed Description
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)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Chronic Myeloid Leukemia
Eligibility Criteria
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
* 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
Inclusion Criteria
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)
* 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)
Gender
All
Gender Based
false
Keywords
Chronic Phase - Chronic Myeloid Leukemia
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01244750
Org Class
Industry
Org Full Name
Bristol-Myers Squibb
Org Study Id
CA180-330
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)
Primary Outcomes
Outcome Measure
The rate of Complete Cytogenetic Response
Outcome Time Frame
12 months
Outcome Description
Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)
Outcome Measure
The duration of initial TKI treatment
Outcome Time Frame
5-years from study index date
Outcome Description
Dates of switches in therapy from initial TKI treatment, Reasons for treatment discontinuation (i.e. side effects, mutations, etc.), Subsequent lines of CML treatments (start and stop dates)
Outcome Measure
The rate of discontinuation and treatment changes after initial TKI treatment
Outcome Time Frame
Every 6 months for a follow-up period of 5-years from study index date
Outcome Description
Results and dates of: all bone marrow aspirates, blood tests, cytogenetics, Polymerase Chain Reaction (PCR), Fluorescent In-Situ Hybridization (FISH), and Physical exam
Outcome Measure
The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response)
Outcome Time Frame
Every 6 months for a follow-up period of 5-years from study index date
Outcome Description
Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.
Outcome Measure
The adherence to treatment
Outcome Time Frame
Every 6 months for a follow-up period of 5-years from study index date
Secondary Outcomes
Outcome Description
Questionnaires used for assessment:
Functional Assessment of Cancer Therapy - General (FACT-G), Cancer Therapy Satisfaction Questionnaire (CTSQ), MD Anderson Symptom Inventory - CML (MDASI-CML).
Functional Assessment of Cancer Therapy - General (FACT-G), Cancer Therapy Satisfaction Questionnaire (CTSQ), MD Anderson Symptom Inventory - CML (MDASI-CML).
Outcome Time Frame
Every 6 months
Outcome Measure
Impact of first-line treatment options on quality of life
Outcome Description
Treatment discontinuations and changes
Outcome Time Frame
Every 6 months
Outcome Measure
Non-hematologic side effects from treatment affecting patient quality of life and outcomes
Outcome Description
Cancer Therapy Satisfaction Questionnaire (CTSQ)
Outcome Time Frame
Every 6 months
Outcome Measure
Patient satisfaction with CML treatment
Outcome Description
MD Anderson Symptom Inventory - CML (MDASI-CML) Questionnaire - disease-specific module of the MDASI7 which is a brief measure of severity and impact of cancer-related symptoms on daily function
Outcome Time Frame
Every 6 months
Outcome Measure
Patterns of disease monitoring as observed in a real-world setting
Outcome Description
To evaluate healthcare resource utilization, descriptive statistics will describe real-world disease monitoring patterns, frequency of testing, and resources used for disease management for each treatment cohort.
Outcome Time Frame
Every 6 months
Outcome Measure
Resource utilization associated with CML management
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients will be recruited at oncology practices or oncology centers linked to a hospital in the North Americas, Europe and potentially at additional sites in South America, and Asia
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Olga Derman
Investigator Email
ODERMAN@montefiore.org
Investigator Phone
Categories Mesh Debug
Blood & Bone Marrow Cancers --- LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE
Blood & Bone Marrow Cancers --- LEUKEMIA, MYELOID
Cancer --- LEUKEMIA
Blood & Bone Marrow Cancers --- LEUKEMIA
Cancer --- NEOPLASMS
Blood & Bone Marrow Cancers --- MYELOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- BONE MARROW DISEASES
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
MeSH Terms
LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE
LEUKEMIA, MYELOID, CHRONIC-PHASE
LEUKEMIA, MYELOID
LEUKEMIA
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
MYELOPROLIFERATIVE DISORDERS
BONE MARROW DISEASES
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
CHRONIC DISEASE
DISEASE ATTRIBUTES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS