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


N/A
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia, Newly Diagnosed

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

David Marin, Consultant Haematology

Investigator Role:

Study Director

Investigator Affiliation:

Imperial College Healthcare NHS Trust

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

MADA1012

NCT ID:

NCT00632255

Start Date:

January 2008

Completion Date:

May 2009

Related Keywords:

  • Chronic Myeloid Leukemia
  • Newly Diagnosed
  • Chronic Myeloid Leukemia
  • Long term Imatinib therapy compliance
  • Newly diagnosed
  • Late side effects
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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