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Completed

NCT Number: NCT01243489

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

compliance supporting measures

Other

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

Primary outcomes

  1. Patients compliance

    Time frame: 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 outcomes

  1. Compliance

    Time frame: 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

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Other

Collaborators

  • Crolll Gmbh

Registry information

Official study 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

Acronym: Crescendo

Important dates

Study start
2010
Primary completion
2013
Study completion
2018
First posted
Nov 18, 2010
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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