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CompletedNCT01243489CrescendoUpdated Dec 20, 2019

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

A Phase 4 interventional study of compliance supporting measures in Chronic Myelogenous Leukemia (CML), sponsored by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH. Completed at 23 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-20.

Sponsored by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
104
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 104 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • Other
    patient diary

    compliance supporting measure: patients uses patient diary from month 6 to 12

    Other: compliance supporting measures

  • Other
    Information service "Leben mit CML"

    compliance supporting measure: patient uses the Information service "Leben mit CML"

    Other: compliance supporting measures

Interventions

  • Othercompliance 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

06

What researchers measure

Primary outcomes

  1. Patients compliance

    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 outcomes

  1. 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

    Time frame: 12 months

  2. efficacy of imatinib

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

    Time frame: 12 months

07

Study locations

23 sites
  • Onkologische Schwerpunktpraxis Celle
    Celle, 29221, Germany
  • Onkozentrum Dresden, Gemeinschaftspraxis Dres. Göhler & Dörfel
    Dresden, 01127, Germany
  • Gemeinschaftspraxis Hämatologie - Onkologie, BAG Freiberg-Richter / Jacobasch / Illmer / Wolf
    Dresden, 01307, Germany
  • Gemeinschaftspraxis für Hämatologie und Onkologie
    Erfurt, 99085, Germany
  • St.-Antonius-Hospital, Klinik für Hämatologie und Onkologie
    Eschweiler, 52249, Germany
  • IFS - Interdisziplinäres Facharztzentrum Sachsenhausen
    Frankfurt, 60596, Germany
  • Hämato-Onkologische Schwerpunktpraxis, Dres. Michael Metz, Andreas Ammon, Dirk Meyer
    Göttingen, 37073, Germany
  • MediProjekt, Gesellschaft für Medizinstatistik und Projektentwicklung
    Hannover, 30171, Germany
  • Praxis für Innere Medizin, Onkologie und Hämatologie, Dr. Hahnfeld
    Jena, 07743, Germany
  • Universitätsklinikum Jena, Klinik für Innere Medizin II
    Jena, 07747, Germany
  • Gemeinschaftspraxis Dr. Siehl, Dr. Söling und Prof. Dr. Hirschmann
    Kassel, 34117, Germany
  • Gemeinschaftspraxis, Dres. Neise, Lollert
    Krefeld, 47805, Germany
  • Gemeinschaftspraxis, Dres. Ursula Vehling-Kaiser, Doris Greif
    Landshut, 84028, Germany
  • Internistische Schwerpunktpraxis Dr. Tschechne
    Lehrte, 31275, Germany
  • Onkologische Schwerpunktpraxis, Dres. Uthgenannt, Kisro, Weber
    Lübeck, 23562, Germany
  • Onkonet GbR, Praxis Dres. Weidenbach & Balser
    Marburg, 35037, Germany
  • Hämatologisch onkologische Schwerpunktpraxis
    Mayen, 56727, Germany
  • Nordbadpraxis
    München, 80797, Germany
  • Hämato - Onkologische Praxisgemeinschaft, Dr. Schmidt
    München, 81241, Germany
  • Praxis Dr. Walter
    Paderborn, 33102, Germany
  • Fachärzte für Innere Medizin, Hämatologie & Onkologie Rostock
    Rostock, 56727, Germany
  • Hämatologisch-Onkologische Gemeinschaftspraxis Würselen
    Würselen, 52146, Germany
  • Gemeinschaftspraxis für Innere Medizin, Hämatologie und Internistische Onkologie
    Würzburg, 97970, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01243489
Lead sponsor
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Collaborators
Crolll Gmbh
Responsible party
Sponsor
First posted
Nov 18, 2010
Start date
Oct 2010
Primary completion
Jun 2013
Completion
Jun 2018
Last update
Dec 20, 2019

Study contacts

Andreas Hochhaus, Professor, MD
principal investigator · Universitätsklinikum Jena, Klinik für Innere Medizin II

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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