Chronic Myeloid Leukemia
Conditions
Keywords
Chronic Phase - Chronic Myeloid Leukemia
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.
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)
Interventions
None listed
Sponsors
ICON Clinical Research
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The adherence to treatment | Every 6 months for a follow-up period of 5-years from study index date | Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence. |
| The rate of Complete Cytogenetic Response | 12 months | — |
| The duration of initial TKI treatment | 5-years from study index date | Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib) |
| The rate of discontinuation and treatment changes after initial TKI treatment | Every 6 months for a follow-up period of 5-years from study index date | 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) |
| The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response) | Every 6 months for a follow-up period of 5-years from study index date | Results and dates of: all bone marrow aspirates, blood tests, cytogenetics, Polymerase Chain Reaction (PCR), Fluorescent In-Situ Hybridization (FISH), and Physical exam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of first-line treatment options on quality of life | Every 6 months | Questionnaires used for assessment: Functional Assessment of Cancer Therapy - General (FACT-G), Cancer Therapy Satisfaction Questionnaire (CTSQ), MD Anderson Symptom Inventory - CML (MDASI-CML). |
| Non-hematologic side effects from treatment affecting patient quality of life and outcomes | Every 6 months | Treatment discontinuations and changes |
| Patient satisfaction with CML treatment | Every 6 months | Cancer Therapy Satisfaction Questionnaire (CTSQ) |
| Patterns of disease monitoring as observed in a real-world setting | Every 6 months | 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 |
| Resource utilization associated with CML management | Every 6 months | 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. |
Countries
France, Germany, Italy, Netherlands, Puerto Rico, Russia, Spain, United States
Outcome results
None listed