Back to resultsCompliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation (Crescendo)
Primary Purpose
Chronic Myelogenous Leukemia (CML)
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
compliance supporting measures
Sponsored by
About this trial
This is an interventional other trial for Chronic Myelogenous Leukemia (CML) focused on measuring CML, compliance, compliance supporting measures, complete cytogenetic response, mayor molecular remission, Philadelphia chromosome, BCR-ABL, Imatinib, tyrosine kinase inhibitor, smart blister
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
Sites / Locations
- Onkologische Schwerpunktpraxis Celle
- Onkozentrum Dresden, Gemeinschaftspraxis Dres. Göhler & Dörfel
- Gemeinschaftspraxis Hämatologie - Onkologie, BAG Freiberg-Richter / Jacobasch / Illmer / Wolf
- Gemeinschaftspraxis für Hämatologie und Onkologie
- St.-Antonius-Hospital, Klinik für Hämatologie und Onkologie
- IFS - Interdisziplinäres Facharztzentrum Sachsenhausen
- Hämato-Onkologische Schwerpunktpraxis, Dres. Michael Metz, Andreas Ammon, Dirk Meyer
- MediProjekt, Gesellschaft für Medizinstatistik und Projektentwicklung
- Praxis für Innere Medizin, Onkologie und Hämatologie, Dr. Hahnfeld
- Universitätsklinikum Jena, Klinik für Innere Medizin II
- Gemeinschaftspraxis Dr. Siehl, Dr. Söling und Prof. Dr. Hirschmann
- Gemeinschaftspraxis, Dres. Neise, Lollert
- Gemeinschaftspraxis, Dres. Ursula Vehling-Kaiser, Doris Greif
- Internistische Schwerpunktpraxis Dr. Tschechne
- Onkologische Schwerpunktpraxis, Dres. Uthgenannt, Kisro, Weber
- Onkonet GbR, Praxis Dres. Weidenbach & Balser
- Hämatologisch onkologische Schwerpunktpraxis
- Nordbadpraxis
- Hämato - Onkologische Praxisgemeinschaft, Dr. Schmidt
- Praxis Dr. Walter
- Fachärzte für Innere Medizin, Hämatologie & Onkologie Rostock
- Hämatologisch-Onkologische Gemeinschaftspraxis Würselen
- Gemeinschaftspraxis für Innere Medizin, Hämatologie und Internistische Onkologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
patient diary
Information service "Leben mit CML"
Arm Description
compliance supporting measure: patients uses patient diary from month 6 to 12
compliance supporting measure: patient uses the Information service "Leben mit CML"
Outcomes
Primary Outcome Measures
Patients compliance
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
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
efficacy of imatinib
to monitor the efficacy of imatinib as assessed by cytogenetics and PCR testing (BCR-ABL load, % IS)
Full Information
NCT ID
NCT01243489
First Posted
November 17, 2010
Last Updated
December 18, 2019
Sponsor
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Collaborators
Crolll Gmbh
1. Study Identification
Unique Protocol Identification Number
NCT01243489
Brief Title
Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation
Acronym
Crescendo
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Collaborators
Crolll Gmbh
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient diary
Arm Type
Other
Arm Description
compliance supporting measure: patients uses patient diary from month 6 to 12
Arm Title
Information service "Leben mit CML"
Arm Type
Other
Arm Description
compliance supporting measure: patient uses the Information service "Leben mit CML"
Intervention Type
Other
Intervention Name(s)
compliance supporting measures
Intervention Description
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
Primary Outcome Measure Information:
Title
Patients compliance
Description
To assess patients compliance before and after intervention by comparison of the number of imatinib (Glivec®) tablets taken before and after intervention
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Compliance
Description
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
Time Frame
12 months
Title
efficacy of imatinib
Description
to monitor the efficacy of imatinib as assessed by cytogenetics and PCR testing (BCR-ABL load, % IS)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Hochhaus, Professor, MD
Organizational Affiliation
Universitätsklinikum Jena, Klinik für Innere Medizin II
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onkologische Schwerpunktpraxis Celle
City
Celle
ZIP/Postal Code
29221
Country
Germany
Facility Name
Onkozentrum Dresden, Gemeinschaftspraxis Dres. Göhler & Dörfel
City
Dresden
ZIP/Postal Code
01127
Country
Germany
Facility Name
Gemeinschaftspraxis Hämatologie - Onkologie, BAG Freiberg-Richter / Jacobasch / Illmer / Wolf
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Gemeinschaftspraxis für Hämatologie und Onkologie
City
Erfurt
ZIP/Postal Code
99085
Country
Germany
Facility Name
St.-Antonius-Hospital, Klinik für Hämatologie und Onkologie
City
Eschweiler
ZIP/Postal Code
52249
Country
Germany
Facility Name
IFS - Interdisziplinäres Facharztzentrum Sachsenhausen
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Hämato-Onkologische Schwerpunktpraxis, Dres. Michael Metz, Andreas Ammon, Dirk Meyer
City
Göttingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
MediProjekt, Gesellschaft für Medizinstatistik und Projektentwicklung
City
Hannover
ZIP/Postal Code
30171
Country
Germany
Facility Name
Praxis für Innere Medizin, Onkologie und Hämatologie, Dr. Hahnfeld
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Universitätsklinikum Jena, Klinik für Innere Medizin II
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Siehl, Dr. Söling und Prof. Dr. Hirschmann
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
Gemeinschaftspraxis, Dres. Neise, Lollert
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Facility Name
Gemeinschaftspraxis, Dres. Ursula Vehling-Kaiser, Doris Greif
City
Landshut
ZIP/Postal Code
84028
Country
Germany
Facility Name
Internistische Schwerpunktpraxis Dr. Tschechne
City
Lehrte
ZIP/Postal Code
31275
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis, Dres. Uthgenannt, Kisro, Weber
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Onkonet GbR, Praxis Dres. Weidenbach & Balser
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Hämatologisch onkologische Schwerpunktpraxis
City
Mayen
ZIP/Postal Code
56727
Country
Germany
Facility Name
Nordbadpraxis
City
München
ZIP/Postal Code
80797
Country
Germany
Facility Name
Hämato - Onkologische Praxisgemeinschaft, Dr. Schmidt
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
Praxis Dr. Walter
City
Paderborn
ZIP/Postal Code
33102
Country
Germany
Facility Name
Fachärzte für Innere Medizin, Hämatologie & Onkologie Rostock
City
Rostock
ZIP/Postal Code
56727
Country
Germany
Facility Name
Hämatologisch-Onkologische Gemeinschaftspraxis Würselen
City
Würselen
ZIP/Postal Code
52146
Country
Germany
Facility Name
Gemeinschaftspraxis für Innere Medizin, Hämatologie und Internistische Onkologie
City
Würzburg
ZIP/Postal Code
97970
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation
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