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

NCT02348957 | Completed DMC

• 1 other identifier: OMC 2014-I
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 66

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.

Conditions

Myeloid Leukemia, Chronic, Chronic-Phase

Keywords

Chronic myeloid leukemia; Dasatinib; Any line; Chronic phase

Outcome Measures

Primary Outcomes (1)

• Distribution of Molecular remission status at study entry and after 12 months.

  Patients included into this study are on a treatment with Dasatinib. Fraction of BCR-ABL positive cells is measured at study entry or was assessed at the timepoint of Dasatinib treatment begin and classified as \>MR3, MR3, MR4, and MR4.5 as an ordinal measure. Molecular Fraction of BCR-ABL positive cells is reassessed after 12 months.

  12 Months

Secondary Outcomes (15)

• Distribution of Molecular remission status at study entry and after 24 months.

  24 months

• Best possible response

  Up to 36 months

• Time to Molecular remission

  up to 36 months

• Time molecular progression

  Up to 36 months

• Cytogenetic profile at start of Dasatinib treatment, type of BCR-ABL transcript (if these parameters are routinely tested at the facility and are documented for the NIS).

  Up to 36 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This non-interventional study will document around 300 adult patients with newly-diagnosed CP-CML and CML patients in chronic phase resistant or intolerant to prior therapies, including Imatinib and Nilotinib.

You may qualify if:

• 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.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Onco Medical Consult GmbH: lead

Study Sites (66)

Praxis für Hämatologie und internistische Onkologie

Heidenheim, Baden-Wurttemberg, 89518, Germany

Location

Ambulantes Therapiezentrum

Offenburg, Baden-Wurttemberg, 77654, Germany

Location

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

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

Location

Praxisklinik für integrative Onkologie

Altötting, Bavaria, 84503, Germany

Location

Gemeinschaftspraxis Drs. Klausmann

Aschaffenburg, Bavaria, 63739, Germany

Location

Klinikum Aschaffenburg Hämato-Onkologische Schwerpunktpraxis

Aschaffenburg, Bavaria, 63739, Germany

Location

Onkologische Gemeinschaftspraxis

Bamberg, Bavaria, 96049, Germany

Location

Klinikum Bayreuth Klinik für Hämatologie und Onkologie

Bayreuth, Bavaria, 95445, Germany

Location

Schwerpunktpraxis für Hämatologie und Onkologie

Bayreuth, Bavaria, 95445, Germany

Location

Onkologische Schwerpunktpraxis

Kronach, Bavaria, 96317, Germany

Location

Hämatologie Onkologie Palliativmedizin Tagesklinik Landshut

Landshut, Bavaria, 84028, Germany

Location

Facharztpraxis für Hämatologie und Onkologie, München

München, Bavaria, 80331, Germany

Location

Praxis für Hämatologie und Onkologie am Isartor

München, Bavaria, 80331, Germany

Location

MOP-Studiengesellschaft

München, Bavaria, 80335, Germany

Location

Schwerpunktpraxis und Tagesklinik dür Hämatologie und Onkologie/OncoPRO GbR

Regensburg, Bavaria, 93053, Germany

Location

Fachärztliche Gemeinschaftspraxis

Weiden, Bavaria, 92637, Germany

Location

MVZ für Blut- und Krebserkrankungen Potsdam

Potsdam, Brandenburg, 14467, Germany

Location

Onkologische Schwerpunktpraxis und Tagesklinik

Bad Soden am Taunus, Hesse, 65812, Germany

Location

Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

Frankfurt am Main, Hesse, 60389, Germany

Location

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

Göttingen, Hesse, 37073, Germany

Location

Onkologische Schwerpunktpraxis

Hanau, Hesse, 63450, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie

Langen, Hesse, 63225, Germany

Location

Dres. Klaus Maria Josten und Ortwin Klein

Wiesbaden, Hesse, 65191, Germany

Location

Onkologische Kooperation Harz

Goslar, Lower Saxony, 38642, Germany

Location

Onkologisches Ambulanzzentrum Hannover

Hanover, Lower Saxony, 30171, Germany

Location

Praxis für Hämatologie und Onkologie

Hanover, Lower Saxony, 30625, Germany

Location

Onkologische Schwerpunktpraxis Hildesheim

Hildesheim, Lower Saxony, 31135, Germany

Location

Schwerpunktpraxis

Neustadt am Rübenberge, Lower Saxony, 31535, Germany

Location

Intern. Gemeinschaftspraxis

Güstrow, Mecklenburg-Vorpommern, 18273, Germany

Location

Gemeinschaftspraxis für Hämatologie/Onkologie

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Hämatologisch-onkologische Gemeinschaftspraxis Nordhorn

Nordhorn, Niedersachen, 48527, Germany

Location

MVZ Arnsberg

Arnsberg, North Rhine-Westphalia, 59755, Germany

Location

Vinzenz Pallotti Hospital GmbH

Bergisch Gladbach, North Rhine-Westphalia, 51429, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie

Cologne, North Rhine-Westphalia, 50677, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie / Ambulante Tumortherapie

Cologne, North Rhine-Westphalia, 51103, Germany

Location

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

Düren, North Rhine-Westphalia, 52353, Germany

Location

Onko.Logix GmbH & Co. KG

Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

Location

Praxis für Hämatologie und Onkologie

Hamm, North Rhine-Westphalia, 59065, Germany

Location

Praxisklinik Hämatologie/Onkologie Herne

Herne, North Rhine-Westphalia, 44623, Germany

Location

Klinikum Lippe Onkologie und Hämatologie

Lemgo, North Rhine-Westphalia, 32657, Germany

Location

Praxis für Hämatologie, Onkologie und Palliativmed

Mönchengladbach, North Rhine-Westphalia, 41066, Germany

Location

Onkologische Schwerpunktpraxis Mülheim an der Ruhr und Oberhausen

Mülheim, North Rhine-Westphalia, 45468, Germany

Location

Onkologische Praxis Remscheid

Remscheid, North Rhine-Westphalia, 42589, Germany

Location

Klinikum Idar-Oberstein GmbH Medizinische Klinik I

Idar-Oberstein, Rhineland-Palatinate, 55743, Germany

Location

IDGGQ, Institut für med. Dokumentation GbR

Kaiserslautern, Rhineland-Palatinate, 67655, Germany

Location

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

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

CaritasKlinikum Saarbrücken St. Theresia Akademisches Lehrkrankenhaus der Universität des Saarlandes

Saarbrücken, Saarland, 66113, Germany

Location

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

Saarbrücken, Saarland, 66113, Germany

Location

Onkologische Praxis Bautzen

Bautzen, Saxony, 02625, Germany

Location

Klinikum Chemnitz gGmbH Klinik für Innere Medizin III

Chemnitz, Saxony, 09113, Germany

Location

Internistische Praxis & Tagesklinik

Neustadt, Saxony, 01844, Germany

Location

Ambulante Onkologie Ostsachsen

Zittau, Saxony, 02763, Germany

Location

Hämato-onkologische Praxis

Halberstadt, Saxony-Anhalt, 38820, Germany

Location

Gemeinschaftspraxis

Eisenach, Thuringia, 99817, Germany

Location

Onkologische Schwerpunktpraxis Augsburg

Augsburg, 86152, Germany

Location

OVZ Friedrichshain Hämatologie, Onkologie und Palliativmedizin

Berlin, 10407, Germany

Location

Krebsheilkunde Lichtenberg

Berlin, 13055, Germany

Location

Praxis für Innere Medizin Ärztehaus Berlin-Pankow

Berlin, 13187, Germany

Location

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

Berlin, 13353, Germany

Location

Onkologie Duisburg Nord

Duisburg, 47166, Germany

Location

Onkologie Lerchenfeld

Hamburg, 22081, Germany

Location

Onkologie Hof - Medizinisches Versorgungszentrum GmbH

Hof, 95028, Germany

Location

Hämatologische Praxisgemeinschaft München

München, 81241, Germany

Location

Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie

Singen, 78224, Germany

Location

Onkologische Schwerpunktpraxis Trier St. Anna / Brüderkrankenhaus

Trier, 54292, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie

Westerstede, 26655, Germany

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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

Study Officials

• Hans Tesch, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: January 28, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 25, 2019

Record last verified: 2018-07

Locations

DE (66)