Clinical trial NCT02348957: Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib
Official title: Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib PCR-Monitoring, Adherence, Quality of Life, Therapy Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myeloid Leukemia, Chronic, Chronic-Phase
Keywords: Chronic myeloid leukemia
Dasatinib
Any line
Chronic phase
Lead sponsor: Onco Medical Consult GmbH
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Distribution of Molecular remission status at study entry and after 12 months.
timeFrame: 12 Months
Secondary outcomes:
measure: Distribution of Molecular remission status at study entry and after 24 months.
timeFrame: 24 months
measure: Best possible response
timeFrame: Up to 36 months
measure: Time to Molecular remission
timeFrame: up to 36 months
measure: Time molecular progression
timeFrame: Up to 36 months
measure: 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).
timeFrame: Up to 36 months
measure: Hematologic response (HR) and complete blood count (if these parameters are routinely tested at the facility and are documented for the NIS)
timeFrame: Up to 36 months
measure: Patient Compliance/Adherence
timeFrame: After 3,6,12,24 months
measure: Patients' Satisfaction
timeFrame: After 3,6,12,24 months
measure: Quality of Life
timeFrame: Time after 3,6,12,24 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Time after 3,6,12,24 months
measure: Subgroup analysis concerning the primary study objective
timeFrame: 12 months
measure: Subgroup analysis concerning the time to remission
timeFrame: Up to 36 months
measure: Subgroup analysis concerning the time to progression
timeFrame: Up to 36 months
measure: Subgroup analysis concerning the quality of life and patient compliance
timeFrame: Time after 3,6,12,24 months
measure: Subgroup analyses of participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Time after 3,6,12,24 months
Other outcomes:
Locations:
city: Heidenheim
country: Germany
facility: Praxis für Hämatologie und internistische Onkologie
state: Baden-Württemberg
city: Offenburg
country: Germany
facility: Ambulantes Therapiezentrum
state: Baden-Württemberg
city: Schwäbisch Hall
country: Germany
facility: Diakonie-Klinikum Schwäbisch Hall GmbH, Klinik für Innere Medizin III
state: Baden-Württemberg
city: Altötting
country: Germany
facility: Praxisklinik für integrative Onkologie
state: Bayern
city: Aschaffenburg
country: Germany
facility: Gemeinschaftspraxis Drs. Klausmann
state: Bayern
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg Hämato-Onkologische Schwerpunktpraxis
state: Bayern
city: Bamberg
country: Germany
facility: Onkologische Gemeinschaftspraxis
state: Bayern
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth Klinik für Hämatologie und Onkologie
state: Bayern
city: Bayreuth
country: Germany
facility: Schwerpunktpraxis für Hämatologie und Onkologie
state: Bayern
city: Kronach
country: Germany
facility: Onkologische Schwerpunktpraxis
state: Bayern
city: Landshut
country: Germany
facility: Hämatologie Onkologie Palliativmedizin Tagesklinik Landshut
state: Bayern
city: München
country: Germany
facility: Facharztpraxis für Hämatologie und Onkologie, München
state: Bayern
city: München
country: Germany
facility: Praxis für Hämatologie und Onkologie am Isartor
state: Bayern
city: München
country: Germany
facility: MOP-Studiengesellschaft
state: Bayern
city: Regensburg
country: Germany
facility: Schwerpunktpraxis und Tagesklinik dür Hämatologie und Onkologie/OncoPRO GbR
state: Bayern
city: Weiden
country: Germany
facility: Fachärztliche Gemeinschaftspraxis
state: Bayern
city: Potsdam
country: Germany
facility: MVZ für Blut- und Krebserkrankungen Potsdam
state: Brandenburg
city: Bad Soden am Taunus
country: Germany
facility: Onkologische Schwerpunktpraxis und Tagesklinik
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
state: Hessen
city: Göttingen
country: Germany
facility: Gemeinschaftspraxis Dres med. Dirk Meyer & Andreas Ammon und Michael Metz
state: Hessen
city: Hanau
country: Germany
facility: Onkologische Schwerpunktpraxis
state: Hessen
city: Langen
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
state: Hessen
city: Wiesbaden
country: Germany
facility: Dres. Klaus Maria Josten und Ortwin Klein
state: Hessen
city: Güstrow
country: Germany
facility: Intern. Gemeinschaftspraxis
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
facility: Gemeinschaftspraxis für Hämatologie/Onkologie
state: Mecklenburg-Vorpommern
city: Nordhorn
country: Germany
facility: Hämatologisch-onkologische Gemeinschaftspraxis Nordhorn
state: Niedersachen
city: Goslar
country: Germany
facility: Onkologische Kooperation Harz
state: Niedersachsen
city: Hannover
country: Germany
facility: Onkologisches Ambulanzzentrum Hannover
state: Niedersachsen
city: Hannover
country: Germany
facility: Praxis für Hämatologie und Onkologie
state: Niedersachsen
city: Hildesheim
country: Germany
facility: Onkologische Schwerpunktpraxis Hildesheim
state: Niedersachsen
city: Neustadt am Rübenberge
country: Germany
facility: Schwerpunktpraxis
state: Niedersachsen
city: Arnsberg
country: Germany
facility: MVZ Arnsberg
state: Nordrhein-Westfalen
city: Bergisch Gladbach
country: Germany
facility: Vinzenz Pallotti Hospital GmbH
state: Nordrhein-Westfalen
city: Düren
country: Germany
facility: Medizinisches Versorgungszentrum (MVZ) an der St. Marien-Hospital Düren gGmbH
state: Nordrhein-Westfalen
city: Gelsenkirchen
country: Germany
facility: Onko.Logix GmbH & Co. KG
state: Nordrhein-Westfalen
city: Hamm
country: Germany
facility: Praxis für Hämatologie und Onkologie
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: Praxisklinik Hämatologie/Onkologie Herne
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie / Ambulante Tumortherapie
state: Nordrhein-Westfalen
city: Lemgo
country: Germany
facility: Klinikum Lippe Onkologie und Hämatologie
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
facility: Praxis für Hämatologie, Onkologie und Palliativmed
state: Nordrhein-Westfalen
city: Mülheim an der Ruhr
country: Germany
facility: Onkologische Schwerpunktpraxis Mülheim an der Ruhr und Oberhausen
state: Nordrhein-Westfalen
city: Remscheid
country: Germany
facility: Onkologische Praxis Remscheid
state: Nordrhein-Westfalen
city: Idar-Oberstein
country: Germany
facility: Klinikum Idar-Oberstein GmbH Medizinische Klinik I
state: Rheinland-Pfalz
city: Kaiserslautern
country: Germany
facility: IDGGQ, Institut für med. Dokumentation GbR
state: Rheinland-Pfalz
city: Koblenz
country: Germany
facility: Praxisklinik für Hämatologie und Onkologie Koblenz/ Institut für Versorgungsforschung in der Onkologie GbR
state: Rheinland-Pfalz
city: Saarbrücken
country: Germany
facility: CaritasKlinikum Saarbrücken St. Theresia Akademisches Lehrkrankenhaus der Universität des Saarlandes
state: Saarland
city: Saarbrücken
country: Germany
facility: Gemeinschaftspraxis Drs. Georg Jacobs, Prof Heiner Daus und PD Dr. Schmits
state: Saarland
city: Halberstadt
country: Germany
facility: Hämato-onkologische Praxis
state: Sachsen-Anhalt
city: Bautzen
country: Germany
facility: Onkologische Praxis Bautzen
state: Sachsen
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH Klinik für Innere Medizin III
state: Sachsen
city: Neustadt
country: Germany
facility: Internistische Praxis & Tagesklinik
state: Sachsen
city: Zittau
country: Germany
facility: Ambulante Onkologie Ostsachsen
state: Sachsen
city: Eisenach
country: Germany
facility: Gemeinschaftspraxis
state: Thüringen
city: Augsburg
country: Germany
facility: Onkologische Schwerpunktpraxis Augsburg
city: Berlin
country: Germany
facility: OVZ Friedrichshain Hämatologie, Onkologie und Palliativmedizin
city: Berlin
country: Germany
facility: Krebsheilkunde Lichtenberg
city: Berlin
country: Germany
facility: Praxis für Innere Medizin Ärztehaus Berlin-Pankow
city: Berlin
country: Germany
facility: Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie Charité - Universitätsmedizin Berlin
city: Duisburg
country: Germany
facility: Onkologie Duisburg Nord
city: Hamburg
country: Germany
facility: Onkologie Lerchenfeld
city: Hof
country: Germany
facility: Onkologie Hof - Medizinisches Versorgungszentrum GmbH
city: München
country: Germany
facility: Hämatologische Praxisgemeinschaft München
city: Singen
country: Germany
facility: Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie
city: Trier
country: Germany
facility: Onkologische Schwerpunktpraxis Trier St. Anna / Brüderkrankenhaus
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
Study officials:
affiliation: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus, Im Prüfling 17, D-60389 Frankfurt am Main
name: Hans Tesch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: