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

Myeloid Leukemia, Chronic, Chronic-Phase Clinical Trial

— DasPAQT  

Official title:

Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib PCR-Monitoring, Adherence, Quality of Life, Therapy Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348957
• Other study ID #: OMC 2014-I
• Status: Completed
• Start date: October 2014
• Est. completion date: May 2019

Study information

• Verified date: July 2018
• Source: Onco Medical Consult GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Praxisklinik für integrative Onkologie	Altötting	Bayern
Germany	MVZ Arnsberg	Arnsberg	Nordrhein-Westfalen
Germany	Gemeinschaftspraxis Drs. Klausmann	Aschaffenburg	Bayern
Germany	Klinikum Aschaffenburg Hämato-Onkologische Schwerpunktpraxis	Aschaffenburg	Bayern
Germany	Onkologische Schwerpunktpraxis Augsburg	Augsburg
Germany	Onkologische Schwerpunktpraxis und Tagesklinik	Bad Soden am Taunus	Hessen
Germany	Onkologische Gemeinschaftspraxis	Bamberg	Bayern
Germany	Onkologische Praxis Bautzen	Bautzen	Sachsen
Germany	Klinikum Bayreuth Klinik für Hämatologie und Onkologie	Bayreuth	Bayern
Germany	Schwerpunktpraxis für Hämatologie und Onkologie	Bayreuth	Bayern
Germany	Vinzenz Pallotti Hospital GmbH	Bergisch Gladbach	Nordrhein-Westfalen
Germany	Krebsheilkunde Lichtenberg	Berlin
Germany	Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie Charité - Universitätsmedizin Berlin	Berlin
Germany	OVZ Friedrichshain Hämatologie, Onkologie und Palliativmedizin	Berlin
Germany	Praxis für Innere Medizin Ärztehaus Berlin-Pankow	Berlin
Germany	Klinikum Chemnitz gGmbH Klinik für Innere Medizin III	Chemnitz	Sachsen
Germany	Onkologie Duisburg Nord	Duisburg
Germany	Medizinisches Versorgungszentrum (MVZ) an der St. Marien-Hospital Düren gGmbH	Düren	Nordrhein-Westfalen
Germany	Gemeinschaftspraxis	Eisenach	Thüringen
Germany	Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus	Frankfurt am Main	Hessen
Germany	Onko.Logix GmbH & Co. KG	Gelsenkirchen	Nordrhein-Westfalen
Germany	Onkologische Kooperation Harz	Goslar	Niedersachsen
Germany	Gemeinschaftspraxis Dres med. Dirk Meyer & Andreas Ammon und Michael Metz	Göttingen	Hessen
Germany	Intern. Gemeinschaftspraxis	Güstrow	Mecklenburg-Vorpommern
Germany	Hämato-onkologische Praxis	Halberstadt	Sachsen-Anhalt
Germany	Onkologie Lerchenfeld	Hamburg
Germany	Praxis für Hämatologie und Onkologie	Hamm	Nordrhein-Westfalen
Germany	Onkologische Schwerpunktpraxis	Hanau	Hessen
Germany	Onkologisches Ambulanzzentrum Hannover	Hannover	Niedersachsen
Germany	Praxis für Hämatologie und Onkologie	Hannover	Niedersachsen
Germany	Praxis für Hämatologie und internistische Onkologie	Heidenheim	Baden-Württemberg
Germany	Praxisklinik Hämatologie/Onkologie Herne	Herne	Nordrhein-Westfalen
Germany	Onkologische Schwerpunktpraxis Hildesheim	Hildesheim	Niedersachsen
Germany	Onkologie Hof - Medizinisches Versorgungszentrum GmbH	Hof
Germany	Klinikum Idar-Oberstein GmbH Medizinische Klinik I	Idar-Oberstein	Rheinland-Pfalz
Germany	IDGGQ, Institut für med. Dokumentation GbR	Kaiserslautern	Rheinland-Pfalz
Germany	Praxisklinik für Hämatologie und Onkologie Koblenz/ Institut für Versorgungsforschung in der Onkologie GbR	Koblenz	Rheinland-Pfalz
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie	Köln	Nordrhein-Westfalen
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie / Ambulante Tumortherapie	Köln	Nordrhein-Westfalen
Germany	Onkologische Schwerpunktpraxis	Kronach	Bayern
Germany	Hämatologie Onkologie Palliativmedizin Tagesklinik Landshut	Landshut	Bayern
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie	Langen	Hessen
Germany	Klinikum Lippe Onkologie und Hämatologie	Lemgo	Nordrhein-Westfalen
Germany	Praxis für Hämatologie, Onkologie und Palliativmed	Mönchengladbach	Nordrhein-Westfalen
Germany	Onkologische Schwerpunktpraxis Mülheim an der Ruhr und Oberhausen	Mülheim an der Ruhr	Nordrhein-Westfalen
Germany	Facharztpraxis für Hämatologie und Onkologie, München	München	Bayern
Germany	Hämatologische Praxisgemeinschaft München	München
Germany	MOP-Studiengesellschaft	München	Bayern
Germany	Praxis für Hämatologie und Onkologie am Isartor	München	Bayern
Germany	Internistische Praxis & Tagesklinik	Neustadt	Sachsen
Germany	Schwerpunktpraxis	Neustadt am Rübenberge	Niedersachsen
Germany	Hämatologisch-onkologische Gemeinschaftspraxis Nordhorn	Nordhorn	Niedersachen
Germany	Ambulantes Therapiezentrum	Offenburg	Baden-Württemberg
Germany	MVZ für Blut- und Krebserkrankungen Potsdam	Potsdam	Brandenburg
Germany	Schwerpunktpraxis und Tagesklinik dür Hämatologie und Onkologie/OncoPRO GbR	Regensburg	Bayern
Germany	Onkologische Praxis Remscheid	Remscheid	Nordrhein-Westfalen
Germany	Gemeinschaftspraxis für Hämatologie/Onkologie	Rostock	Mecklenburg-Vorpommern
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	Diakonie-Klinikum Schwäbisch Hall GmbH, Klinik für Innere Medizin III	Schwäbisch Hall	Baden-Württemberg
Germany	Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie	Singen
Germany	Onkologische Schwerpunktpraxis Trier St. Anna / Brüderkrankenhaus	Trier
Germany	Fachärztliche Gemeinschaftspraxis	Weiden	Bayern
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie	Westerstede
Germany	Dres. Klaus Maria Josten und Ortwin Klein	Wiesbaden	Hessen
Germany	Ambulante Onkologie Ostsachsen	Zittau	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Onco Medical Consult GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Distribution of Molecular remission status at study entry and after 24 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 time point 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 24 months.	24 months
Secondary	Best possible response	Defined as the best response at any time after the start of the treatment. Reported will be distributions for each response (progression, stable disease, remission for at least one class of MR)	Up to 36 months
Secondary	Time to Molecular remission	Patients reach this event, when a change from a higher amount of BCR-ABL positive patients to a lower amount of BCR-ABL positive patients occurs	up to 36 months
Secondary	Time molecular progression	Patients start the observation period at study entry and reach this event, when a change to a higher BCR-ABL remission status is reached.	Up to 36 months
Secondary	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).	Cytogenetic response according to conventional cytogenetics (evaluation of at least 20 metaphase chromosomes) and hyper metaphase FISH (if applicable)	Up to 36 months
Secondary	Hematologic response (HR) and complete blood count (if these parameters are routinely tested at the facility and are documented for the NIS)	Complete blood count (if these parameters are routinely tested at the facility and are documented for the NIS	Up to 36 months
Secondary	Patient Compliance/Adherence	Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.	After 3,6,12,24 months
Secondary	Patients' Satisfaction	Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.	After 3,6,12,24 months
Secondary	Quality of Life	Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.	Time after 3,6,12,24 months
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.	Time after 3,6,12,24 months
Secondary	Subgroup analysis concerning the primary study objective	Common influencing factors like prognostic scores or previous therapy patterns are analyzed, whether they have an influence on the primary study aim.	12 months
Secondary	Subgroup analysis concerning the time to remission	Common influencing factors like prognostic scores or previous therapy patterns are analyzed, whether they have an influence on time to remission	Up to 36 months
Secondary	Subgroup analysis concerning the time to progression	Common influencing factors like age, sex or previous therapy patterns are analyzed, whether they have an influence on time to progression	Up to 36 months
Secondary	Subgroup analysis concerning the quality of life and patient compliance	Common influencing factors like age, sex, comorbidities or previous therapy patterns are analyzed, whether they have an influence on quality of life and patient compliance	Time after 3,6,12,24 months
Secondary	Subgroup analyses of participants with Adverse Events as a Measure of Safety and Tolerability	Common influencing factors like age, sex, comorbidities or previous therapy patterns are analyzed, whether they have an influence on safety and toxicity	Time after 3,6,12,24 months