Long Term Therapy With Imatinib: Development of Late Side Effects and Compliance to Treatment
Imatinib has revolutionised the treatment of chronic myeloid leukaemia (CML). The first clinical trials were conducted in 1998 in patients with advanced disease, and by 2002 imatinib was established as the standard therapy for all patients including those recently diagnosed. In spite of overwhelming evidence about its efficacy we still need to gain more knowledge about issues related to long term treatment with imatinib such as why some patients respond better than others, the development of side effects and the quality of life.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Compliance to Long Term Imatinib Therapy in Newly Diagnosed Patients With Chronic Myeloid Leukaemia.|
|Study Start Date:||January 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Patients with CML who have been treated with Imatinib (Glivec) within 6 months of diagnosis as first line therapy. Initial therapy with Hydroxyurea is permitted
Conventional therapy with imatinib
We plan to follow prospectively a cohort of CML patients in order to study their compliance to therapy,pharmacological levels of imatinib and the prevalence of side effects. We expect to be able to correlate the actual dose received, the pharmacological levels of drug in blood, with the change in the level of residual disease (measured by Q−PCR) at various time points. We also want to gain insight into the relationship between compliance to therapy and specific side effects and between compliance and duration of treatment. We will also assess the adherence to imatinib therapy after increases in the drug dose that are part of standard treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632255
|Haematology Department. Catherine Lewis Centre. Hammersmith Hospital. Du Cane Road.|
|London, United Kingdom, W12 0HS|
|Study Director:||David Marin, Consultant Haematology||Imperial College Healthcare NHS Trust|