Status:
COMPLETED
Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation
Lead Sponsor:
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Collaborating Sponsors:
Crolll Gmbh
Conditions:
Chronic Myelogenous Leukemia (CML)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 phy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01243489
Start Date
October 1 2010
End Date
June 1 2018
Last Update
December 20 2019
Active Locations (23)
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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