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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00632255
Other study ID # MADA1012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2008
Est. completion date May 2009

Study information

Verified date July 2019
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Unable to give consent.

- Unable to communicate with the medical and nursing staff

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Imatinib
Conventional therapy with imatinib

Locations

Country Name City State
United Kingdom Haematology Department. Catherine Lewis Centre. Hammersmith Hospital. Du Cane Road. London

Sponsors (2)

Lead Sponsor Collaborator
Imperial College London Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Marin D, Bazeos A, Mahon FX, Eliasson L, Milojkovic D, Bua M, Apperley JF, Szydlo R, Desai R, Kozlowski K, Paliompeis C, Latham V, Foroni L, Molimard M, Reid A, Rezvani K, de Lavallade H, Guallar C, Goldman J, Khorashad JS. Adherence is the critical facto — View Citation

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