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

Sponsor
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH (Other)
Overall Status
Completed
CT.gov ID
NCT01243489
Collaborator
Crolll Gmbh (Other)
104
23
2
92
4.5
0

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: compliance supporting measures
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Patients compliance [12 months]

    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

  1. Compliance [12 months]

    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

  2. efficacy of imatinib [12 months]

    to monitor the efficacy of imatinib as assessed by cytogenetics and PCR testing (BCR-ABL load, % IS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Onkologische Schwerpunktpraxis Celle Celle Germany 29221
2 Onkozentrum Dresden, Gemeinschaftspraxis Dres. Göhler & Dörfel Dresden Germany 01127
3 Gemeinschaftspraxis Hämatologie - Onkologie, BAG Freiberg-Richter / Jacobasch / Illmer / Wolf Dresden Germany 01307
4 Gemeinschaftspraxis für Hämatologie und Onkologie Erfurt Germany 99085
5 St.-Antonius-Hospital, Klinik für Hämatologie und Onkologie Eschweiler Germany 52249
6 IFS - Interdisziplinäres Facharztzentrum Sachsenhausen Frankfurt Germany 60596
7 Hämato-Onkologische Schwerpunktpraxis, Dres. Michael Metz, Andreas Ammon, Dirk Meyer Göttingen Germany 37073
8 MediProjekt, Gesellschaft für Medizinstatistik und Projektentwicklung Hannover Germany 30171
9 Praxis für Innere Medizin, Onkologie und Hämatologie, Dr. Hahnfeld Jena Germany 07743
10 Universitätsklinikum Jena, Klinik für Innere Medizin II Jena Germany 07747
11 Gemeinschaftspraxis Dr. Siehl, Dr. Söling und Prof. Dr. Hirschmann Kassel Germany 34117
12 Gemeinschaftspraxis, Dres. Neise, Lollert Krefeld Germany 47805
13 Gemeinschaftspraxis, Dres. Ursula Vehling-Kaiser, Doris Greif Landshut Germany 84028
14 Internistische Schwerpunktpraxis Dr. Tschechne Lehrte Germany 31275
15 Onkologische Schwerpunktpraxis, Dres. Uthgenannt, Kisro, Weber Lübeck Germany 23562
16 Onkonet GbR, Praxis Dres. Weidenbach & Balser Marburg Germany 35037
17 Hämatologisch onkologische Schwerpunktpraxis Mayen Germany 56727
18 Nordbadpraxis München Germany 80797
19 Hämato - Onkologische Praxisgemeinschaft, Dr. Schmidt München Germany 81241
20 Praxis Dr. Walter Paderborn Germany 33102
21 Fachärzte für Innere Medizin, Hämatologie & Onkologie Rostock Rostock Germany 56727
22 Hämatologisch-Onkologische Gemeinschaftspraxis Würselen Würselen Germany 52146
23 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
ClinicalTrials.gov Identifier:
NCT01243489
Other Study ID Numbers:
  • CSTI571ADE75T
  • 2010-018339-16
First Posted:
Nov 18, 2010
Last Update Posted:
Dec 20, 2019
Last Verified:
Dec 1, 2019

Study Results

No Results Posted as of Dec 20, 2019