Myeloid Leukemia, Chronic, Chronic-Phase Clinical Trial
Official title:
Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib PCR-Monitoring, Adherence, Quality of Life, Therapy Satisfaction
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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