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

Chronic Myelogenous Leukemia (CML) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243489
• Other study ID #: CSTI571ADE75T
• Secondary ID: 2010-018339-16
• Status: Completed
• Phase: Phase 4
• Start date: October 2010
• Est. completion date: June 2018

Study information

• Verified date: December 2019
• Source: Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2018
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia (CML)
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Philadelphia Chromosome

Intervention

Other:
• 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

Locations

Country	Name	City	State
Germany	Onkologische Schwerpunktpraxis Celle	Celle
Germany	Gemeinschaftspraxis Hämatologie - Onkologie, BAG Freiberg-Richter / Jacobasch / Illmer / Wolf	Dresden
Germany	Onkozentrum Dresden, Gemeinschaftspraxis Dres. Göhler & Dörfel	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	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	Hämato - Onkologische Praxisgemeinschaft, Dr. Schmidt	München
Germany	Nordbadpraxis	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

Sponsors (2)

Lead Sponsor	Collaborator
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH	Crolll Gmbh

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients compliance	To assess patients compliance before and after intervention by comparison of the number of imatinib (Glivec®) tablets taken before and after intervention	12 months
Secondary	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	12 months
Secondary	efficacy of imatinib	to monitor the efficacy of imatinib as assessed by cytogenetics and PCR testing (BCR-ABL load, % IS)	12 months