Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation

Study Overview
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Brief Summary
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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.

Official Title
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CRESCENDO (Compliance: Role Emerges for Success in CML: Evaluation aND Optimisation): A Prospective, Multi-center, Phase IV Study to Assess the Compliance in Patients With Philadelphia Chromosome-positive (Ph+) and/or BCR-ABL Positive Chronic Myelogenous Leukaemia (CML) Under Long-term Imatinib Therapy

Conditions
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Chronic Myelogenous Leukemia (CML)

Intervention / Treatment
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* Other: compliance supporting measures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patient diary<br>compliance supporting measure: patients uses patient diary from month 6 to 12 | Other: compliance supporting measures<br>* 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<br>|
| Other: Information service Leben mit CML<br>compliance supporting measure: patient uses the Information service Leben mit CML | Other: compliance supporting measures<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients compliance | To assess patients compliance before and after intervention by comparison of the number of imatinib (Glivec®) tablets taken before and after intervention | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | 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 | 12 months | 
| efficacy of imatinib | to monitor the efficacy of imatinib as assessed by cytogenetics and PCR testing (BCR-ABL load, % IS) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BCR-ABL, CML, compliance, compliance supporting measures, complete cytogenetic response, mayor molecular remission, Philadelphia chromosome, Imatinib, tyrosine kinase inhibitor, smart blister