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

Sponsor

Imperial College London (Other)

Overall Status

Completed

CT.gov ID

NCT00632255

Collaborator

Novartis Pharmaceuticals (Industry)

Enrollment

Location

Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia Newly Diagnosed	Drug: Imatinib

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

88 participants

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 :

Jan 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
1 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	Drug: Imatinib Conventional therapy with imatinib

Arm

Intervention/Treatment

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

Drug: Imatinib

Conventional therapy with imatinib

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.