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

NCT01243489 | Completed Phase 4

• 2 other identifiers: CSTI571ADE75T2010-018339-16
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 23

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.

Conditions

Chronic Myelogenous Leukemia (CML)

Keywords

CML; compliance; compliance supporting measures; complete cytogenetic response; mayor molecular remission; Philadelphia chromosome; BCR-ABL; Imatinib; tyrosine kinase inhibitor; smart blister

Outcome Measures

Primary Outcomes (1)

• Patients compliance

  To assess patients compliance before and after intervention by comparison of the number of imatinib (Glivec®) tablets taken before and after intervention

  12 months

Secondary Outcomes (2)

• Compliance

  12 months

• efficacy of imatinib

  12 months

Study Arms (2)

patient diary

OTHER

compliance supporting measure: patients uses patient diary from month 6 to 12

Other: compliance supporting measures

Information service "Leben mit CML"

OTHER

compliance supporting measure: patient uses the Information service "Leben mit CML"

Other: compliance supporting measures

Interventions

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

Information service "Leben mit CML"; patient diary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH: lead
• Crolll Gmbh: collaborator

Study Sites (23)

Onkologische Schwerpunktpraxis Celle

Celle, 29221, Germany

Location

Onkozentrum Dresden, Gemeinschaftspraxis Dres. Göhler & Dörfel

Dresden, 01127, Germany

Location

Gemeinschaftspraxis Hämatologie - Onkologie, BAG Freiberg-Richter / Jacobasch / Illmer / Wolf

Dresden, 01307, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie

Erfurt, 99085, Germany

Location

St.-Antonius-Hospital, Klinik für Hämatologie und Onkologie

Eschweiler, 52249, Germany

Location

IFS - Interdisziplinäres Facharztzentrum Sachsenhausen

Frankfurt, 60596, Germany

Location

Hämato-Onkologische Schwerpunktpraxis, Dres. Michael Metz, Andreas Ammon, Dirk Meyer

Göttingen, 37073, Germany

Location

MediProjekt, Gesellschaft für Medizinstatistik und Projektentwicklung

Hanover, 30171, Germany

Location

Praxis für Innere Medizin, Onkologie und Hämatologie, Dr. Hahnfeld

Jena, 07743, Germany

Location

Universitätsklinikum Jena, Klinik für Innere Medizin II

Jena, 07747, Germany

Location

Gemeinschaftspraxis Dr. Siehl, Dr. Söling und Prof. Dr. Hirschmann

Kassel, 34117, Germany

Location

Gemeinschaftspraxis, Dres. Neise, Lollert

Krefeld, 47805, Germany

Location

Gemeinschaftspraxis, Dres. Ursula Vehling-Kaiser, Doris Greif

Landshut, 84028, Germany

Location

Internistische Schwerpunktpraxis Dr. Tschechne

Lehrte, 31275, Germany

Location

Onkologische Schwerpunktpraxis, Dres. Uthgenannt, Kisro, Weber

Lübeck, 23562, Germany

Location

Onkonet GbR, Praxis Dres. Weidenbach & Balser

Marburg, 35037, Germany

Location

Hämatologisch onkologische Schwerpunktpraxis

Mayen, 56727, Germany

Location

Nordbadpraxis

München, 80797, Germany

Location

Hämato - Onkologische Praxisgemeinschaft, Dr. Schmidt

München, 81241, Germany

Location

Praxis Dr. Walter

Paderborn, 33102, Germany

Location

Fachärzte für Innere Medizin, Hämatologie & Onkologie Rostock

Rostock, 56727, Germany

Location

Hämatologisch-Onkologische Gemeinschaftspraxis Würselen

Würselen, 52146, Germany

Location

Gemeinschaftspraxis für Innere Medizin, Hämatologie und Internistische Onkologie

Würzburg, 97970, Germany

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Patient Compliance; Philadelphia Chromosome

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Translocation, Genetic; Chromosome Aberrations

Study Officials

• Andreas Hochhaus, Professor, MD

  Universitätsklinikum Jena, Klinik für Innere Medizin II

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 18, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2018
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

DE (23)