Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib

NCT ID: NCT02348957

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 223 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2019-05-31

Brief Summary

CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Dasatinib is approved for the treatment of newly diagnosed PH+ CP-CML and CML in chronic or accelerated phase or blast crisis in patients resistant or intolerant to prior therapies including Imatinib. Although Imatinib has demonstrated unprecedented efficacy in clinical trials, mostly in chronic phase CML, there is lack of published data on how CML is managed in real-life clinical practice settings. Therefore this non-interventional study is designed to collect real-life data on CML-treatment with Dasatinib in clinical routine with respect to first and second line treatment and/or switch setting (within 1st line or from 1st line TKI to 2nd line Dasatinib). Emphasis lies on health care provided in registered doctor's practices as here most of CML patients who are not involved in clinical trials are treated.

Detailed Description

The advent of Imatinib into the market in 2001 changed the treatment paradigm of CML. Seven-year follow-up from the IRIS trial revealed an estimated overall survival of 86% in newly diagnosed CML patients treated with Imatinib.

In June 2006, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Dasatinib to treat adults with CP-CML with resistant disease or who were intolerant to prior therapy, including Imatinib. The FDA converted Dasatinib to a regular approval in May 2009, after confirmation of the treatment's safety and effectiveness. On October 28, 2010, FDA granted accelerated approval to Dasatinib for the treatment of newly diagnosed adult patients with CML-CP. Dasatinib entered thereby a marketplace with other TKIs including Nilotinib.

According to the summary of product characteristics brochure Dasatinib (Sprycel®) is indicated for the treatment of adult patients with:

• Newly diagnosed Ph+ CML In the chronic phase.
• Chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including Imatinib mesilate.
• Ph+ acute lymphoblastic leukaemia and lymoid blast CML with resistance or intolerance to prior therapy.

A phase III study (DASISION) of Dasatinib vs. Imatinib could proof that Dasatinib induced significantly higher and faster rates of complete cytogenetic response and major molecular response when compared to Imatinib. Since achieving complete cytogenetic response within 12 months has been associated with better long-term, progression-free survival, Dasatinib may improve the long-term outcomes among patients with newly diagnosed chronic-phase CML.

Nevertheless, further data are required to obtain additional information on the clinical benefits of Dasatinib.

CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Dasatinib is approved for the treatment of newly diagnosed PH+ CP-CML and CML in chronic or accelerated phase or blast crisis in patients resistant or intolerant to prior therapies including Imatinib. Although Imatinib has demonstrated exceptional efficacy in clinical trials, mostly in chronic phase CML, there is lack of published data on how CML is managed in real-life clinical practice settings.

Therefore this non-interventional study is designed to collect real-life data on CML-treatment with Dasatinib in clinical routine with respect to first and second line treatment and/or switch setting (within 1st line or from 1st line TKI to 2nd line Dasatinib). Emphasis lies on health care provided in registered doctor's practices as here most of CML patients who are not involved in clinical trials are treated.

Conditions

Myeloid Leukemia, Chronic, Chronic-Phase

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with newly diagnosed CP-CML and CML patients in chronic phase resistant or intolerant to prior therapies, including Imatinib. Any line treatment of chronic CML.
• 18 years or older at time of diagnosis
• Receiving treatment with Dasatinib according to the SmPC
• Written informed consent obtained before any screening procedure and according to local guidelines

Exclusion Criteria

•Patients who are participating in a clinical trial for CML treatment will be excluded

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Onco Medical Consult GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Tesch, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus, Im Prüfling 17, D-60389 Frankfurt am Main

Locations

Praxis für Hämatologie und internistische Onkologie

Heidenheim, Baden-Wurttemberg, Germany

Ambulantes Therapiezentrum

Offenburg, Baden-Wurttemberg, Germany

Diakonie-Klinikum Schwäbisch Hall GmbH, Klinik für Innere Medizin III

Schwäbisch Hall, Baden-Wurttemberg, Germany

Praxisklinik für integrative Onkologie

Altötting, Bavaria, Germany

Gemeinschaftspraxis Drs. Klausmann

Aschaffenburg, Bavaria, Germany

Klinikum Aschaffenburg Hämato-Onkologische Schwerpunktpraxis

Aschaffenburg, Bavaria, Germany

Onkologische Gemeinschaftspraxis

Bamberg, Bavaria, Germany

Klinikum Bayreuth Klinik für Hämatologie und Onkologie

Bayreuth, Bavaria, Germany

Schwerpunktpraxis für Hämatologie und Onkologie

Bayreuth, Bavaria, Germany

Onkologische Schwerpunktpraxis

Kronach, Bavaria, Germany

Hämatologie Onkologie Palliativmedizin Tagesklinik Landshut

Landshut, Bavaria, Germany

Facharztpraxis für Hämatologie und Onkologie, München

München, Bavaria, Germany

Praxis für Hämatologie und Onkologie am Isartor

München, Bavaria, Germany

MOP-Studiengesellschaft

München, Bavaria, Germany

Schwerpunktpraxis und Tagesklinik dür Hämatologie und Onkologie/OncoPRO GbR

Regensburg, Bavaria, Germany

Fachärztliche Gemeinschaftspraxis

Weiden, Bavaria, Germany

MVZ für Blut- und Krebserkrankungen Potsdam

Potsdam, Brandenburg, Germany

Onkologische Schwerpunktpraxis und Tagesklinik

Bad Soden am Taunus, Hesse, Germany

Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

Frankfurt am Main, Hesse, Germany

Gemeinschaftspraxis Dres med. Dirk Meyer & Andreas Ammon und Michael Metz

Göttingen, Hesse, Germany

Onkologische Schwerpunktpraxis

Hanau, Hesse, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie

Langen, Hesse, Germany

Dres. Klaus Maria Josten und Ortwin Klein

Wiesbaden, Hesse, Germany

Onkologische Kooperation Harz

Goslar, Lower Saxony, Germany

Onkologisches Ambulanzzentrum Hannover

Hanover, Lower Saxony, Germany

Praxis für Hämatologie und Onkologie

Hanover, Lower Saxony, Germany

Onkologische Schwerpunktpraxis Hildesheim

Hildesheim, Lower Saxony, Germany

Schwerpunktpraxis

Neustadt am Rübenberge, Lower Saxony, Germany

Intern. Gemeinschaftspraxis

Güstrow, Mecklenburg-Vorpommern, Germany

Gemeinschaftspraxis für Hämatologie/Onkologie

Rostock, Mecklenburg-Vorpommern, Germany

Hämatologisch-onkologische Gemeinschaftspraxis Nordhorn

Nordhorn, Niedersachen, Germany

MVZ Arnsberg

Arnsberg, North Rhine-Westphalia, Germany

Vinzenz Pallotti Hospital GmbH

Bergisch Gladbach, North Rhine-Westphalia, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie

Cologne, North Rhine-Westphalia, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie / Ambulante Tumortherapie

Cologne, North Rhine-Westphalia, Germany

Medizinisches Versorgungszentrum (MVZ) an der St. Marien-Hospital Düren gGmbH

Düren, North Rhine-Westphalia, Germany

Onko.Logix GmbH & Co. KG

Gelsenkirchen, North Rhine-Westphalia, Germany

Praxis für Hämatologie und Onkologie

Hamm, North Rhine-Westphalia, Germany

Praxisklinik Hämatologie/Onkologie Herne

Herne, North Rhine-Westphalia, Germany

Klinikum Lippe Onkologie und Hämatologie

Lemgo, North Rhine-Westphalia, Germany

Praxis für Hämatologie, Onkologie und Palliativmed

Mönchengladbach, North Rhine-Westphalia, Germany

Onkologische Schwerpunktpraxis Mülheim an der Ruhr und Oberhausen

Mülheim, North Rhine-Westphalia, Germany

Onkologische Praxis Remscheid

Remscheid, North Rhine-Westphalia, Germany

Klinikum Idar-Oberstein GmbH Medizinische Klinik I

Idar-Oberstein, Rhineland-Palatinate, Germany

IDGGQ, Institut für med. Dokumentation GbR

Kaiserslautern, Rhineland-Palatinate, Germany

Praxisklinik für Hämatologie und Onkologie Koblenz/ Institut für Versorgungsforschung in der Onkologie GbR

Koblenz, Rhineland-Palatinate, Germany

CaritasKlinikum Saarbrücken St. Theresia Akademisches Lehrkrankenhaus der Universität des Saarlandes

Saarbrücken, Saarland, Germany

Gemeinschaftspraxis Drs. Georg Jacobs, Prof Heiner Daus und PD Dr. Schmits

Saarbrücken, Saarland, Germany

Onkologische Praxis Bautzen

Bautzen, Saxony, Germany

Klinikum Chemnitz gGmbH Klinik für Innere Medizin III

Chemnitz, Saxony, Germany

Internistische Praxis & Tagesklinik

Neustadt, Saxony, Germany

Ambulante Onkologie Ostsachsen

Zittau, Saxony, Germany

Hämato-onkologische Praxis

Halberstadt, Saxony-Anhalt, Germany

Gemeinschaftspraxis

Eisenach, Thuringia, Germany

Onkologische Schwerpunktpraxis Augsburg

Augsburg, , Germany

OVZ Friedrichshain Hämatologie, Onkologie und Palliativmedizin

Berlin, , Germany

Krebsheilkunde Lichtenberg

Berlin, , Germany

Praxis für Innere Medizin Ärztehaus Berlin-Pankow

Berlin, , Germany

Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie Charité - Universitätsmedizin Berlin

Berlin, , Germany

Onkologie Duisburg Nord

Duisburg, , Germany

Onkologie Lerchenfeld

Hamburg, , Germany

Onkologie Hof - Medizinisches Versorgungszentrum GmbH

Hof, , Germany

Hämatologische Praxisgemeinschaft München

München, , Germany

Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie

Singen, , Germany

Onkologische Schwerpunktpraxis Trier St. Anna / Brüderkrankenhaus

Trier, , Germany

Gemeinschaftspraxis für Hämatologie und Onkologie

Westerstede, , Germany

Countries

Germany

Other Identifiers

OMC 2014-I

Identifier Type: -

Identifier Source: org_study_id