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

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH23 sites in 1 country104 target enrollmentOctober 2010

ConditionsChronic Myelogenous Leukemia (CML)

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Chronic Myelogenous Leukemia (CML)
Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Enrollment: 104
Locations: 23
Primary Endpoint: Patients compliance
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

June 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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