Clinical trial NCT01243489: Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Myelogenous Leukemia (CML)
Keywords: CML
compliance
compliance supporting measures
complete cytogenetic response
mayor molecular remission
Philadelphia chromosome
BCR-ABL
Imatinib
tyrosine kinase inhibitor
smart blister
Lead sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Sponsor class: OTHER
Collaborators: name: Crolll Gmbh
First posted: 2010-11-18
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patients compliance
timeFrame: 12 months
Secondary outcomes:
measure: Compliance
timeFrame: 12 months
measure: efficacy of imatinib
timeFrame: 12 months
Other outcomes:
Locations:
city: Celle
country: Germany
facility: Onkologische Schwerpunktpraxis Celle
city: Dresden
country: Germany
facility: Onkozentrum Dresden, Gemeinschaftspraxis Dres. Göhler & Dörfel
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Hämatologie - Onkologie, BAG Freiberg-Richter / Jacobasch / Illmer / Wolf
city: Erfurt
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Eschweiler
country: Germany
facility: St.-Antonius-Hospital, Klinik für Hämatologie und Onkologie
city: Frankfurt
country: Germany
facility: IFS - Interdisziplinäres Facharztzentrum Sachsenhausen
city: Göttingen
country: Germany
facility: Hämato-Onkologische Schwerpunktpraxis, Dres. Michael Metz, Andreas Ammon, Dirk Meyer
city: Hannover
country: Germany
facility: MediProjekt, Gesellschaft für Medizinstatistik und Projektentwicklung
city: Jena
country: Germany
facility: Praxis für Innere Medizin, Onkologie und Hämatologie, Dr. Hahnfeld
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Klinik für Innere Medizin II
city: Kassel
country: Germany
facility: Gemeinschaftspraxis Dr. Siehl, Dr. Söling und Prof. Dr. Hirschmann
city: Krefeld
country: Germany
facility: Gemeinschaftspraxis, Dres. Neise, Lollert
city: Landshut
country: Germany
facility: Gemeinschaftspraxis, Dres. Ursula Vehling-Kaiser, Doris Greif
city: Lehrte
country: Germany
facility: Internistische Schwerpunktpraxis Dr. Tschechne
city: Lübeck
country: Germany
facility: Onkologische Schwerpunktpraxis, Dres. Uthgenannt, Kisro, Weber
city: Marburg
country: Germany
facility: Onkonet GbR, Praxis Dres. Weidenbach & Balser
city: Mayen
country: Germany
facility: Hämatologisch onkologische Schwerpunktpraxis
city: München
country: Germany
facility: Nordbadpraxis
city: München
country: Germany
facility: Hämato - Onkologische Praxisgemeinschaft, Dr. Schmidt
city: Paderborn
country: Germany
facility: Praxis Dr. Walter
city: Rostock
country: Germany
facility: Fachärzte für Innere Medizin, Hämatologie & Onkologie Rostock
city: Würselen
country: Germany
facility: Hämatologisch-Onkologische Gemeinschaftspraxis Würselen
city: Würzburg
country: Germany
facility: Gemeinschaftspraxis für Innere Medizin, Hämatologie und Internistische Onkologie
Study officials:
affiliation: Universitätsklinikum Jena, Klinik für Innere Medizin II
name: Andreas Hochhaus, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References: