Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib
Condition: Myeloid Leukemia, Chronic, Chronic-Phase
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Study type: Observational

Summary: 
      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: 
      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.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This non-interventional study will document around 300 adult patients with newly-diagnosed
        CP-CML and CML patients in chronic phase resistant or intolerant to prior therapies,
        including Imatinib and Nilotinib.
      
Keywords: Chronic myeloid leukemia; Dasatinib; Any line; Chronic phase