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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00632255
First received: February 29, 2008
Last updated: October 23, 2009
Last verified: October 2009
  Purpose

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 Intervention
Chronic Myeloid Leukemia
Newly Diagnosed
Drug: Imatinib

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Compliance to Long Term Imatinib Therapy in Newly Diagnosed Patients With Chronic Myeloid Leukaemia.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Enrollment: 88
Study Start Date: January 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with CML who have been treated with imatinib (Glivec®) within 6 months of diagnosis as first line therapy.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632255

Locations
United Kingdom
Haematology Department. Catherine Lewis Centre. Hammersmith Hospital. Du Cane Road.
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
Novartis Pharmaceuticals
Investigators
Study Director: David Marin, Consultant Haematology Imperial College Healthcare NHS Trust
  More Information

No publications provided

Responsible Party: Dr David Marin, Senior Lecturer and Honorary Consultant, MBBS, FRCS, MFPM, Imperial College of London
ClinicalTrials.gov Identifier: NCT00632255     History of Changes
Other Study ID Numbers: MADA1012
Study First Received: February 29, 2008
Last Updated: October 23, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Imperial College London:
Chronic Myeloid Leukemia
Long term Imatinib therapy compliance
Newly diagnosed
Late side effects

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014