Overview

This trial is active, not recruiting.

Condition chronic myelogenous leukemia (cml)
Treatment compliance supporting measures
Phase phase 4
Sponsor Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Collaborator Crolll Gmbh
Start date October 2010
End date October 2014
Trial size 200 participants
Trial identifier NCT01243489, 2010-018339-16, CSTI571ADE75T

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Arm
(Other)
compliance supporting measure: patients uses patient diary from month 6 to 12
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)
compliance supporting measure: patient uses the Information service "Leben mit CML"
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

Primary Outcomes

Measure
Patients compliance
time frame: 12 months

Secondary Outcomes

Measure
Compliance
time frame: 12 months
efficacy of imatinib
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Andreas Hochhaus, Professor, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH.