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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Myelogenous Leukemia (CML)
• Intervention / Treatment: Other: compliance supporting measures

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Celle, Germany, 29221
    • Onkologische Schwerpunktpraxis Celle
  • Dresden, Germany, 01127
    • Onkozentrum Dresden, Gemeinschaftspraxis Dres. Göhler & Dörfel
  • Dresden, Germany, 01307
    • Gemeinschaftspraxis Hämatologie - Onkologie, BAG Freiberg-Richter / Jacobasch / Illmer / Wolf
  • Erfurt, Germany, 99085
    • Gemeinschaftspraxis für Hämatologie und Onkologie
  • Eschweiler, Germany, 52249
    • St.-Antonius-Hospital, Klinik für Hämatologie und Onkologie
  • Frankfurt, Germany, 60596
    • IFS - Interdisziplinäres Facharztzentrum Sachsenhausen
  • Göttingen, Germany, 37073
    • Hämato-Onkologische Schwerpunktpraxis, Dres. Michael Metz, Andreas Ammon, Dirk Meyer
  • Hannover, Germany, 30171
    • Mediprojekt, Gesellschaft für Medizinstatistik und Projektentwicklung
  • Jena, Germany, 07743
    • Praxis für Innere Medizin, Onkologie und Hämatologie, Dr. Hahnfeld
  • Jena, Germany, 07747
    • Universitätsklinikum Jena, Klinik für Innere Medizin II
  • Kassel, Germany, 34117
    • Gemeinschaftspraxis Dr. Siehl, Dr. Söling und Prof. Dr. Hirschmann
  • Krefeld, Germany, 47805
    • Gemeinschaftspraxis, Dres. Neise, Lollert
  • Landshut, Germany, 84028
    • Gemeinschaftspraxis, Dres. Ursula Vehling-Kaiser, Doris Greif
  • Lehrte, Germany, 31275
    • Internistische Schwerpunktpraxis Dr. Tschechne
  • Lübeck, Germany, 23562
    • Onkologische Schwerpunktpraxis, Dres. Uthgenannt, Kisro, Weber
  • Marburg, Germany, 35037
    • Onkonet GbR, Praxis Dres. Weidenbach & Balser
  • Mayen, Germany, 56727
    • Hämatologisch Onkologische Schwerpunktpraxis
  • München, Germany, 80797
    • Nordbadpraxis
  • München, Germany, 81241
    • Hämato - Onkologische Praxisgemeinschaft, Dr. Schmidt
  • Paderborn, Germany, 33102
    • Praxis Dr. Walter
  • Rostock, Germany, 56727
    • Fachärzte für Innere Medizin, Hämatologie & Onkologie Rostock
  • Würselen, Germany, 52146
    • Hämatologisch-Onkologische Gemeinschaftspraxis Würselen
  • Würzburg, Germany, 97970
    • Gemeinschaftspraxis für Innere Medizin, Hämatologie und internistische Onkologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patient diary; compliance supporting measure: patients uses patient diary from month 6 to 12	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
Other: Information service "Leben mit CML"; compliance supporting measure: patient uses the Information service "Leben mit CML"	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
efficacy of imatinib	to monitor the efficacy of imatinib as assessed by cytogenetics and PCR testing (BCR-ABL load, % IS)	12 months

Collaborators and Investigators

• Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
• Collaborators: Crolll Gmbh
• Investigators: Principal Investigator: Andreas Hochhaus, Professor, MD, Universitätsklinikum Jena, Klinik für Innere Medizin II

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 18, 2010

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: compliance; tyrosine kinase inhibitor; CML; Imatinib; BCR-ABL; Philadelphia chromosome; complete cytogenetic response; compliance supporting measures; mayor molecular remission; smart blister
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Chromosome Aberrations; Translocation, Genetic; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
• Other Study ID Numbers: CSTI571ADE75T; 2010-018339-16 (EudraCT Number)