Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation
NCT ID: NCT01243489
Last Updated: 2019-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
104 participants
INTERVENTIONAL
2010-10-31
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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patient diary
compliance supporting measure: patients uses patient diary from month 6 to 12
compliance 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
Information service "Leben mit CML"
compliance supporting measure: patient uses the Information service "Leben mit CML"
compliance 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
Interventions
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compliance 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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Crolll Gmbh
OTHER
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
OTHER
Responsible Party
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Principal Investigators
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Andreas Hochhaus, Professor, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Jena, Klinik für Innere Medizin II
Locations
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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
Hanover, , Germany
Praxis für Innere Medizin, Onkologie und Hämatologie, Dr. Hahnfeld
Jena, , Germany
Universitätsklinikum Jena, Klinik für Innere Medizin II
Jena, , Germany
Gemeinschaftspraxis Dr. Siehl, Dr. Söling und Prof. Dr. Hirschmann
Kassel, , Germany
Gemeinschaftspraxis, Dres. Neise, Lollert
Krefeld, , Germany
Gemeinschaftspraxis, Dres. Ursula Vehling-Kaiser, Doris Greif
Landshut, , Germany
Internistische Schwerpunktpraxis Dr. Tschechne
Lehrte, , Germany
Onkologische Schwerpunktpraxis, Dres. Uthgenannt, Kisro, Weber
Lübeck, , Germany
Onkonet GbR, Praxis Dres. Weidenbach & Balser
Marburg, , Germany
Hämatologisch onkologische Schwerpunktpraxis
Mayen, , Germany
Nordbadpraxis
München, , Germany
Hämato - Onkologische Praxisgemeinschaft, Dr. Schmidt
München, , Germany
Praxis Dr. Walter
Paderborn, , Germany
Fachärzte für Innere Medizin, Hämatologie & Onkologie Rostock
Rostock, , Germany
Hämatologisch-Onkologische Gemeinschaftspraxis Würselen
Würselen, , Germany
Gemeinschaftspraxis für Innere Medizin, Hämatologie und Internistische Onkologie
Würzburg, , Germany
Countries
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Other Identifiers
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2010-018339-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSTI571ADE75T
Identifier Type: -
Identifier Source: org_study_id