Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib

Study Overview
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Brief Summary
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CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Dasatinib is approved for the treatment of newly diagnosed PH+ CP-CML and CML in chronic or accelerated phase or blast crisis in patients resistant or intolerant to prior therapies including Imatinib. Although Imatinib has demonstrated unprecedented efficacy in clinical trials, mostly in chronic phase CML, there is lack of published data on how CML is managed in real-life clinical practice settings. Therefore this non-interventional study is designed to collect real-life data on CML-treatment with Dasatinib in clinical routine with respect to first and second line treatment and/or switch setting (within 1st line or from 1st line TKI to 2nd line Dasatinib). Emphasis lies on health care provided in registered doctor's practices as here most of CML patients who are not involved in clinical trials are treated.

Detailed Description
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The advent of Imatinib into the market in 2001 changed the treatment paradigm of CML. Seven-year follow-up from the IRIS trial revealed an estimated overall survival of 86% in newly diagnosed CML patients treated with Imatinib. In June 2006, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Dasatinib to treat adults with CP-CML with resistant disease or who were intolerant to prior therapy, including Imatinib. The FDA converted Dasatinib to a regular approval in May 2009, after confirmation of the treatment's safety and effectiveness. On October 28, 2010, FDA granted accelerated approval to Dasatinib for the treatment of newly diagnosed adult patients with CML-CP. Dasatinib entered thereby a marketplace with other TKIs including Nilotinib. According to the summary of product characteristics brochure Dasatinib (Sprycel®) is indicated for the treatment of adult patients with: Newly diagnosed Ph+ CML In the chronic phase. Chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including Imatinib mesilate. Ph+ acute lymphoblastic leukaemia and lymoid blast CML with resistance or intolerance to prior therapy. A phase III study (DASISION) of Dasatinib vs. Imatinib could proof that Dasatinib induced significantly higher and faster rates of complete cytogenetic response and major molecular response when compared to Imatinib. Since achieving complete cytogenetic response within 12 months has been associated with better long-term, progression-free survival, Dasatinib may improve the long-term outcomes among patients with newly diagnosed chronic-phase CML. Nevertheless, further data are required to obtain additional information on the clinical benefits of Dasatinib. CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Dasatinib is approved for the treatment of newly diagnosed PH+ CP-CML and CML in chronic or accelerated phase or blast crisis in patients resistant or intolerant to prior therapies including Imatinib. Although Imatinib has demonstrated exceptional efficacy in clinical trials, mostly in chronic phase CML, there is lack of published data on how CML is managed in real-life clinical practice settings. Therefore this non-interventional study is designed to collect real-life data on CML-treatment with Dasatinib in clinical routine with respect to first and second line treatment and/or switch setting (within 1st line or from 1st line TKI to 2nd line Dasatinib). Emphasis lies on health care provided in registered doctor's practices as here most of CML patients who are not involved in clinical trials are treated.

Official Title
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Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib PCR-Monitoring, Adherence, Quality of Life, Therapy Satisfaction

Conditions
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Myeloid Leukemia, Chronic, Chronic-Phase

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly diagnosed CP-CML and CML patients in chronic phase resistant or intolerant to prior therapies, including Imatinib. Any line treatment of chronic CML. 18 years or older at time of diagnosis Receiving treatment with Dasatinib according to the SmPC Written informed consent obtained before any screening procedure and according to local guidelines Exclusion Criteria: •Patients who are participating in a clinical trial for CML treatment will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of Molecular remission status at study entry and after 12 months. | Patients included into this study are on a treatment with Dasatinib. Fraction of BCR-ABL positive cells is measured at study entry or was assessed at the timepoint of Dasatinib treatment begin and classified as >MR3, MR3, MR4, and MR4.5 as an ordinal measure. Molecular Fraction of BCR-ABL positive cells is reassessed after 12 months. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of Molecular remission status at study entry and after 24 months. | Patients included into this study are on a treatment with Dasatinib. Fraction of BCR-ABL positive cells is measured at study entry or was assessed at the time point of Dasatinib treatment begin and classified as >MR3, MR3, MR4, and MR4.5 as an ordinal measure. Molecular Fraction of BCR-ABL positive cells is reassessed after 24 months. | 24 months | 
| Best possible response | Defined as the best response at any time after the start of the treatment. Reported will be distributions for each response (progression, stable disease, remission for at least one class of MR) | Up to 36 months | 
| Time to Molecular remission | Patients reach this event, when a change from a higher amount of BCR-ABL positive patients to a lower amount of BCR-ABL positive patients occurs | up to 36 months | 
| Time molecular progression | Patients start the observation period at study entry and reach this event, when a change to a higher BCR-ABL remission status is reached. | Up to 36 months | 
| Cytogenetic profile at start of Dasatinib treatment, type of BCR-ABL transcript (if these parameters are routinely tested at the facility and are documented for the NIS). | Cytogenetic response according to conventional cytogenetics (evaluation of at least 20 metaphase chromosomes) and hyper metaphase FISH (if applicable) | Up to 36 months | 
| Hematologic response (HR) and complete blood count (if these parameters are routinely tested at the facility and are documented for the NIS) | Complete blood count (if these parameters are routinely tested at the facility and are documented for the NIS | Up to 36 months | 
| Patient Compliance/Adherence | Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation. | After 3,6,12,24 months | 
| Patients' Satisfaction | Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation. | After 3,6,12,24 months | 
| Quality of Life | Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation. | Time after 3,6,12,24 months | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation. | Time after 3,6,12,24 months | 
| Subgroup analysis concerning the primary study objective | Common influencing factors like prognostic scores or previous therapy patterns are analyzed, whether they have an influence on the primary study aim. | 12 months | 
| Subgroup analysis concerning the time to remission | Common influencing factors like prognostic scores or previous therapy patterns are analyzed, whether they have an influence on time to remission | Up to 36 months | 
| Subgroup analysis concerning the time to progression | Common influencing factors like age, sex or previous therapy patterns are analyzed, whether they have an influence on time to progression | Up to 36 months | 
| Subgroup analysis concerning the quality of life and patient compliance | Common influencing factors like age, sex, comorbidities or previous therapy patterns are analyzed, whether they have an influence on quality of life and patient compliance | Time after 3,6,12,24 months | 
| Subgroup analyses of participants with Adverse Events as a Measure of Safety and Tolerability | Common influencing factors like age, sex, comorbidities or previous therapy patterns are analyzed, whether they have an influence on safety and toxicity | Time after 3,6,12,24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic myeloid leukemia, Dasatinib, Any line, Chronic phase