Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation
- Conditions
- Chronic Myelogenous Leukemia (CML)
- Registration Number
- NCT01243489
- Lead Sponsor
- Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (23)
Onkologische Schwerpunktpraxis Celle
🇩🇪Celle, Germany
Onkozentrum Dresden, Gemeinschaftspraxis Dres. Göhler & Dörfel
🇩🇪Dresden, Germany
Gemeinschaftspraxis Hämatologie - Onkologie, BAG Freiberg-Richter / Jacobasch / Illmer / Wolf
🇩🇪Dresden, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
🇩🇪Erfurt, Germany
St.-Antonius-Hospital, Klinik für Hämatologie und Onkologie
🇩🇪Eschweiler, Germany
IFS - Interdisziplinäres Facharztzentrum Sachsenhausen
🇩🇪Frankfurt, Germany
Hämato-Onkologische Schwerpunktpraxis, Dres. Michael Metz, Andreas Ammon, Dirk Meyer
🇩🇪Göttingen, Germany
MediProjekt, Gesellschaft für Medizinstatistik und Projektentwicklung
🇩🇪Hannover, Germany
Praxis für Innere Medizin, Onkologie und Hämatologie, Dr. Hahnfeld
🇩🇪Jena, Germany
Universitätsklinikum Jena, Klinik für Innere Medizin II
🇩🇪Jena, Germany
Scroll for more (13 remaining)Onkologische Schwerpunktpraxis Celle🇩🇪Celle, Germany