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

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Status and phase

Completed

Phase 4

Conditions

Chronic Myelogenous Leukemia (CML)

Treatments

Other: compliance supporting measures

Study type

Interventional

Funder types

Other

Identifiers

NCT01243489

CSTI571ADE75T

2010-018339-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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