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

Phase 4

Completed

• Conditions: Chronic Myelogenous Leukemia (CML)
• Interventions: Other: compliance supporting measures

• 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

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Primary Completion: 2013-06
• Study Completion: 2018-06
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient diary	compliance supporting measures	compliance supporting measure: patients uses patient diary from month 6 to 12
Information service "Leben mit CML"	compliance supporting measures	compliance supporting measure: patient uses the Information service "Leben mit CML"

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

Gemeinschaftspraxis Hämatologie - Onkologie, BAG Freiberg-Richter / Jacobasch / Illmer / Wolf; 🇩🇪 Dresden, Germany

St.-Antonius-Hospital, Klinik für Hämatologie und Onkologie; 🇩🇪 Eschweiler, Germany

Hämato-Onkologische Schwerpunktpraxis, Dres. Michael Metz, Andreas Ammon, Dirk Meyer; 🇩🇪 Göttingen, Germany

MediProjekt, Gesellschaft für Medizinstatistik und Projektentwicklung; 🇩🇪 Hannover, Germany

Universitätsklinikum Jena, Klinik für Innere Medizin II; 🇩🇪 Jena, Germany

Onkonet GbR, Praxis Dres. Weidenbach & Balser; 🇩🇪 Marburg, Germany

Internistische Schwerpunktpraxis Dr. Tschechne; 🇩🇪 Lehrte, Germany

Hämatologisch onkologische Schwerpunktpraxis; 🇩🇪 Mayen, Germany

Praxis Dr. Walter; 🇩🇪 Paderborn, Germany

Hämatologisch-Onkologische Gemeinschaftspraxis Würselen; 🇩🇪 Würselen, Germany

Nordbadpraxis; 🇩🇪 München, Germany

Hämato - Onkologische Praxisgemeinschaft, Dr. Schmidt; 🇩🇪 München, Germany

Gemeinschaftspraxis für Innere Medizin, Hämatologie und Internistische Onkologie; 🇩🇪 Würzburg, Germany

Praxis für Innere Medizin, Onkologie und Hämatologie, Dr. Hahnfeld; 🇩🇪 Jena, Germany

Gemeinschaftspraxis Dr. Siehl, Dr. Söling und Prof. Dr. Hirschmann; 🇩🇪 Kassel, Germany

Onkozentrum Dresden, Gemeinschaftspraxis Dres. Göhler & Dörfel; 🇩🇪 Dresden, Germany

IFS - Interdisziplinäres Facharztzentrum Sachsenhausen; 🇩🇪 Frankfurt, Germany

Onkologische Schwerpunktpraxis, Dres. Uthgenannt, Kisro, Weber; 🇩🇪 Lübeck, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie; 🇩🇪 Erfurt, Germany

Gemeinschaftspraxis, Dres. Neise, Lollert; 🇩🇪 Krefeld, Germany

Gemeinschaftspraxis, Dres. Ursula Vehling-Kaiser, Doris Greif; 🇩🇪 Landshut, Germany

Fachärzte für Innere Medizin, Hämatologie & Onkologie Rostock; 🇩🇪 Rostock, Germany