Chronic Myelogenous Leukemia (CML)
Conditions
Keywords
CML, compliance, compliance supporting measures, complete cytogenetic response, mayor molecular remission, Philadelphia chromosome, BCR-ABL, Imatinib, tyrosine kinase inhibitor, smart blister
Brief summary
This study on patient's compliance in clinical workaday life aims to assess and to improve CML treatment in Germany by means of adherence supporting measures and to increase adherence awareness by physicians and patients.
Interventions
OTHERcompliance supporting measures
Patients will be treated for a total of 12 months, 6 months without and 6 months with compliance supporting measures. Patient can choose between an information service Leben mit CML or the use of a daily diary
Sponsors
Crolll Gmbh
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (\> 18 years) CML patients in the chronic phase * Medical history of cytogenetically confirmed CML-CP by the presence of the Philadelphia chromosome on bone marrow aspirates (a minimum of 20metaphases is required; FISH cannot be used); Philadelphia chromosome negative but BCR- ABL-positive CML patients can be included * ECOG performance status of \< 2 * Imatinib treatment for at least 1 year and showing CCyR or MMR * Prior treatment with chemotherapeutics such as hydroxyurea or interferon- alpha is allowed * Prior periods of accelerated phases are allowed * Negative pregnancy test for female patients of childbearing potential within 7 days before initiation of study drug * Ability to understand and willingness to sign a written informed consent document prior to any study related screening procedures * Written informed consent, including the consent to be called for interviews by the external, neutral institution.
Exclusion criteria
* Patients with prior blast crisis or stem cell transplantation * Patients with severe medical condition(s) that in the discretion of the investigator prohibits participation in the study (e.g., clinically significant heart diseases, uncontrolled diabetes, active or uncontrolled infection, impaired gastrointestinal function/diseases) * Treatment with drugs or substances, especially those known to modify the cytochrome P450 activity, should be either discontinued or exchanged by different medication (see link for complete list of these medications: http://medicine.iupui.edu/flockhart/table.htm.) * Pregnant or breastfeeding women * Male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients compliance | 12 months | To assess patients compliance before and after intervention by comparison of the number of imatinib (Glivec®) tablets taken before and after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance | 12 months | to correlate the compliance assessed by pill count (conventional pill count and pill count using SmartBlister in selected centers) with the results obtained by the questionnaires and interviews |
| efficacy of imatinib | 12 months | to monitor the efficacy of imatinib as assessed by cytogenetics and PCR testing (BCR-ABL load, % IS) |
Countries
Germany
Outcome results
None listed