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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Crolll Gmbh
Information provided by (Responsible Party):
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
ClinicalTrials.gov Identifier:
NCT01243489
First received: November 17, 2010
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Chronic Myelogenous Leukemia (CML)
Other: compliance supporting measures
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH:

Primary Outcome Measures:
  • Patients compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    to monitor the efficacy of imatinib as assessed by cytogenetics and PCR testing (BCR-ABL load, % IS)


Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243489

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

No publications provided

Responsible Party: Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
ClinicalTrials.gov Identifier: NCT01243489     History of Changes
Other Study ID Numbers: CSTI571ADE75T, 2010-018339-16
Study First Received: November 17, 2010
Last Updated: July 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)

Keywords provided by Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH:
CML
compliance
compliance supporting measures
complete cytogenetic response
mayor molecular remission
Philadelphia chromosome
BCR-ABL
Imatinib
tyrosine kinase inhibitor
smart blister

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014