Long Term Therapy With Imatinib: Development of Late Side Effects and Compliance to Treatment

Chronic Myeloid Leukemia Clinical Trial

Official title:

Compliance to Long Term Imatinib Therapy in Newly Diagnosed Patients With Chronic Myeloid Leukaemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632255
• Other study ID #: MADA1012
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Newly Diagnosed

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